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. Author manuscript; available in PMC: 2019 Dec 5.
Published in final edited form as: Circulation. 2010 Jul 12;122(4):406–441. doi: 10.1161/CIR.0b013e3181e8edf1

Table 3.

RCTs of Interventions to Promote PA and Dietary Lifestyle Change: Minority Samples

Reference(s), Year, Study Design/Duration (N) Population/Sample Intervention Outcomes
Calories/Fat/Fruits and Vegetables/Fiber/Sodium BP/Cholesterol/Glucose/PA Weight Hemoglobin A1c
Group-based intervention delivery strategies
 Elder et al,110 1998, 2-group cluster randomized parallel group trial/3-mo posttest and 6 mo (N=408) Adults enrolled in English as second language classes, mean age 28.7 y, ≈50% female, in US <3 y. 87% Hispanic, 66% monthly income <$1099. Nutrition Heart-Health Education: Five 3-h group classes on nutrition/heart health; culturally sensitive classes conducted in English and Spanish.
Stress-management Education: Five 3-h group classes on stress management.
… … Weight loss: Nutrition group: No loss, gain of 2.5 lb at 6 mo vs 0.66 lb gain in Stress group. 141.65 lb (no between-group differences). Total cholesterol, mg/dL: Nutrition group 178.94 at baseline, 166.18 at 6 mo. Within group difference, P<0.01. NSD between groups.
HDL cholesterol, mg/dL: NSD within or between groups.
BP mmHg: significant within-group changes, P<0.001. NSD between groups.
 Hartman et al,96 1997, quasi-experimental design/8 wks (N=204) Low literacy adults nutrition education program for the low income. 94% female, 32% black, 57% income <$10 000/y. I: Received low-fat nutrition education “Help Yourself to Health” in fun and entertaining format; 10 sessions on low-fat nutrition, taught by Nutrition Education Assistants who lived in the community. Groups met at community sites; literacy level addressed.
C: Received usual Expanded Food and Nutrition Education Program—food budgeting, food safety, and healthy eating.
Calories: per 24-h recall.
Energy/kcals: NSD within or between groups.
Total fat (kcals): NSD within or between groups.
… … Total cholesterol (mg/dL), treatment group: NSD within or between groups.
 Howard-Pitney et al,54 2-group cluster RCT≈5 mo (N=351) Adults recruited from adult education classes. 59% Hispanic, 85% women, 66% had reading level at sixth grade level or below, 65% family income <$10 000/y. I: A dietary fat curriculum offered over 20 mo; 2 parts, 6 wks in classroom followed by a 12-wk maintenance intervention; taught by nutrition educators; six 90-min, which were interactive with few written materials, plus skill building, food tastings, and demonstrations of low-fat goals set by participants. 12-wk maintenance intervention (ie, contact every 2 wks by telephone or mail for 6 contacts (to provide support and encouragement); methods and materials tailored for adult with low literacy.
C: General nutrition classes taught by paraprofessional education; designed to improve knowledge and nutrition choices. Addressed food pyramid, food safety and meal planning.
Total fat: per FFQ %cals from fat, change from baseline, I=37.1%–33.2%; vs C=36.4%–35.2%. Significant within-group difference, for I: P=0.01. No between-group differences.
Total fat (g/d): NSD within or between groups.
… BMI: change from baseline. NSD within group or between groups. Cholesterol (mg/dL): change from baseline. NSD within group or between groups.
 Kumanyika et al,42 2005, 2-phase trial, phase 1 all received group classes; phase II 2-group RCT/12 mo (N=87 completed phase II) 100% black, 90% female, mean age ≈44.4 y, ≈67% education >12 y, mean BMI 37.5. Phase I—Group counseling program (HELP): All interested participants enrolled in 10 weekly group weight loss classes; no specific diet or caloric intake specified; subjects encouraged to set personal goals and to self-monitor diet; advice to increase PA was individually tailored to ability and preference. 3 mo after enrollment subjects randomized to phase II interventions:
Classes: HELP classes+group counseling offered biweekly, then monthly vs weekly.
Enhanced self-help: Staff facilitated self-help; subjects received a personalized calendar, a packets describing local resources, a personal diary, a pedometer, and ad hoc telephone support.
UC: No further counseling outside brief counseling at semiannual clinic visits.
… … Weight loss (kg): −1.2±5.2 over entire study period, P<0.05. Neither HELP classes nor self-help was superior to UC during phase II. SBP (mm Hg): −6.5±11 over entire study period, P<0.01; DBP (mm Hg): –4.9±6.8.
No significant changes in total cholesterol, triglycerides, or blood glucose.
 McNabb et al,43 1997, 2-group RCT/1 wk after I finished (N=39) Women recruited from 3 urban black churches. Mean age 56 y, BMI ≥30, 13% <HS education, approximately 54% employed I: PATHWAYS program: 14-wk small lay-led culturally sensitive group sessions at church on diet that included goal setting, problem solving, and instructions to engage in recreational walking administered by lay facilitators at the churches; included use of ethnic foods.
C: Wait-list control.
… … Weight loss (lb): −10.0±10.28 vs C +1.9±4.25, P<0.0001. BMI (kg/m2): I group −1.4±1.61 vs C group 0.6±0.73, P<0.0001, ES=0.65. …
Individual-based intervention delivery strategies
 Ahluwalia et al,93 2007, cluster randomized trial of 20 public housing developments/6 mo (N=173) 100% smokers, mean age 45.5 y, 81.3% black, ≈38% HS education, 42% unemployed, ≈73% monthly income ≤$800. Both arms received 5 sessions of motivational interviewing counseling for F/V or smoking cessation. Self-efficacy and balancing pros and cons of change and 2-dimensional model of cultural sensitivity guided interventions.
Fruit and vegetable intervention (F/V): Received a baa of fresh F/Vs, a cookbook of healthy recipes, dietary education materials, and 2 videos on F/Vs.
Smoking cessation intervention (SC): Received an 8-week supply of nicotine gum and instructions about quitting.
F/V: At 8 weeks and 6 mo, the F/V group consumed 1.58 (P<0.001) and 0.78 (P=0.04), respectively, more F/V servings per day than SC. Completing more motivational interview sessions (P=0.02) and trying more recipes (P=0.02) led to significantly greater increase of F/Vs in the F/V group. … … …
 Eakin et al,44 2007, 2-group RCT/6 mo (N=200) Adults with ≥1 chronic conditions. Mean age 49.5 y, 75% Hispanic, <5 y in US, 79% female, ≈36% <$10 000/y. I: Bilingual health educator provided 2-individual sessions on PA and dietary recommendations (60–90 min) 3 mo apart at home or clinic; feedback on baseline assessment; participants chose PA and diet goal; goal setting, feedback and problem solving plus ID of multilevel/community supports for health behavior change emphasized. 3 follow-up telephone calls during 6-mo intervention; low-literacy letters reminded participants of goals, addressed barriers, and suggested resources; all activities adapted to literacy level (visual aids) and culture; interventions translated into Spanish and validated.
UC: Subjects were mailed a local community resources guide and 3 newsletters on financial management.
Fat/fiber intake per self-report questionnaire: At 6-month the I group had significantly better Fat/fiber intake compared with UC group, P<0.05. PA: Change from B in minutes walked, NSD within or between groups. … …
 Elder et al,144 2006, 3-group RCT/12 mo (N=367) Latina women, mean age 39.7±9.9 y, BMI 28.9–30.4. Retention 76%−82% for 3 groups. Tailored (T): 12 tailored print newsletters with homework assignments mailed weekly.
Promotora (P): Weekly home visits or telephone calls by lay advisor over 14 wks+12 tailored newsletters and homework. Assessment at baseline, 12 wks, and 6 and 12 mo.
C: 12 off-the-shelf materials mailed weekly to home.
Kcal: Promotora 1288.7 vs Tailored 1420.6 vs C 1430.5; P=0.018 at 12 wks, NSD at 6 and 12 mo.
Fat: Promotora 43.1 g vs Tailored 49.8 g, C 49.1 g; P=0.028 at 12 wks, NSD at 6 and 12 mo; ES=0.14.
… … …
 Jacobs et al,45 2004, cluster randomized trial of 22 health departments/12 mo (N=421) 100% low-income female, mean age 59 y, 51% <HS education, 44% from ethnic minority groups. All subjects previously participated in a 1-y diet and PA behavior change program (phase II): North Carolina WISEWOMAN, in which health departments were randomized to the enhanced intervention or the minimal intervention. In phase III, of the 22 health departments who had received the enhanced intervention in phase II, 11 were randomized to Maintenance Special Intervention and 11 were randomized to Maintenance Usual Care.
Maintenance Special Intervention (MSI): Subjects were mailed 6 bimonthly computer-tailored health messages and received 2 telephone calls from health department staff. Intervention materials were based on social cognitive theory, relapse prevention theory, and the transtheoretical model. Tailoring was according to goals, stage of change, knowledge, social support systems, high-risk situations for relapse, and perceived benefits and barriers. Messages were designed for low-literate and low-income.
Maintenance Usual Care (MUC): Received usual follow-up services at the discretion of the health departments. Basic nutrition and PA counseling pamphlets were available.
Both groups maintained low reported intake levels of dietary saturated fat and cholesterol. Both groups maintained low levels of self-reported PA. Subjects in MSI were more likely to move forward into more advanced stages of PA, P=0.02. … …
 Resnicow et al,103 2005, 3-group cluster randomized trial/1 y (N=906) Mean age 46.3 y, 76.2% female, 100% black, 60% income ≥$40 000/y, >70% some college. C: Standard commercial self-help videos and brochures matched for intensity and type with group 2 materials.
Culturally targeted self-help nutrition and PA: Culturally tailored nutrition video, cookbook, exercise video, exercise guide, and audio cassette.
Motivational Interview (Ml) plus group 2 intervention: 4 Ml sessions delivered by telephone at 4,12, 26, and 40 wks. Two calls address F/V and 2 call addressed PA. Self-help materials reviewed during calls.
FN: Ml increased F&V intake compared with other 2 groups, P<0.05. PA: Total min/wk of PA Increased in Cultural and Ml groups compared with C, P<0.05. NSD between culture and Ml. … …
Multicomponent intervention delivery strategies
 Albright et al,46 2005, 2-group RCT/10 wks, 6 mo, and 1 y (N=72) Sedentary low-income women recruited from adult education sites, mean age 32 y, 73% Hispanic, ≈70% income <$20 000/y. All received 8 weekly 1-h PA skill-building classes taught by ethnically matched educators; included small group discussions and Q&A; Goal 30 min of moderate PA 5 days/wk. After classes, subjects randomized to:
Home-based telephone+mail support (P+MS): Weekly telephone counseling for first 4 wks, biweekly for 8 wks, then monthly, calls 10 mo; pedometers, accompanied by counseling and provision of feedback; women provided large magnetic, erasable monthly calendar to attach to refrigerator and record number of steps.
Home-based mail suddoi! (MS): Monthly newsletters with postage paid mail-back card to report number of steps and PA in last week; feedback sheets were sent from health educator based on responses; prizes earned for mailing back (eg, pens, waist packs, mugs).
Both groups incorporated people, places, language, and clothing familiar to culture; addressed core values.
… PA: At 10-wk P+MS+263 kcal/wk vs MS 294 kcal/wk, NSD between or within groups.
10-week to 12 mo change, P+MS: added increase of 52 kcal/wk vs MS: 1014 kcal/wk less, between group difference, P<0.045, ES=0.24.
… …
 Buller et al,74 1999, 2-group RCT/6 and 18 mo (N=766) Employees from 93 work groups. Mean age 43 y, 43% Hispanic, 6% black, 75% men, ≈13% ≤11th grade education. All received general 5-a-day info over 18 mo.
Peer Education (PE): last 9 months of the general program. Subjects had individual sessions with peer leader and peer-led group discussions about F/V; activities for children; print materials about F/V. Materials to support behavioral skills (ie, F/V calendar, recipes); addressed cultural trends in diet, low-literacy graphics, and stories.
General Education only: No peer education during last 9 mo.
F/V: in PE group at 18 mo, 0.77 and 0.46 increases in daily F/V servings per FFQ, and recall P<0.001, P=0.002, respectively. … … …
 Campbell et al,76 1999, cluster randomized 2-group RCT/2 y (N=2519) Recruited from 50 black churches in 10 rural North Carolina counties. 98% black, mean age 53.8 y, 73% female, 59% income <$20 000, 67% ≥HS education. I: 5-a-day program—20-mo individual, social network and community-level activities emphasizing F/V ≥2 educational sessions regarding modifying cooking methods, served more F/V at church functions; community coalitions included church members, local agencies, grocers, and farmers to plan community events; church-initiated activities. Materials promoted locally grown produce; lay health advisors attended bimonthly training sessions to provide social support and advance stage of change; pastors promoted project.
C: Delayed intervention—no program until the final follow-up.
F/V servings per FFQ: at 2-y follow-up, the 5-a-day group consumed 0.85 F/V servings more than the delayed intervention group, P<0.001. … … …
 Coates et al,47 1999, 2-group RCT/6, 12, 18 mos (N=2208) 100% female, mean age 60 y, 28% black, 16% Hispanic, recruited from clinics located in 3 southern states, 16% <$15 000 income, 11% <HS education. I: Vanguard Women’s Health Trial modified to include additional goals.
A nutritionist assigned personal fat g goals and delivered ≈10 group sessions with decreasing frequency over 2-y period. For individuals having difficulty, nutritionists provided individualized sessions; each session included nutrition and behavior change strategies, cultural (regional/ethnic foods), language and low-literacy sensitive information was used; sessions included regional and ethnic foods. Staff from varied racial/ethnic backgrounds.
C: Subjects received package of standard materials on good dietary practices including the Dietary Guidelines for Americans.
Cal Energy (kcal): At 18 mo, between-group (I vs C) difference of −233 (−355,−111); Fruits (servings): l-C difference of 0.53 (0.33, 0.73); Vegetables (servings): I-C difference of 0.27 (0.07, 0.47); Fat (% of energy): I-C difference of −11.62 (−13.07, −10.17); Sat Fat % of energy: I-C difference of −3.54 (−4.09, −2.99); cholesterol (mg): −74.1 (−100.5, −47.6). … … …
 Fries et al,81 2005, 2-group RCT/1, 6, and 12 mo (N=622) Individuals from 3 rural Virginia physician practices. 36.7% black, mean age 46 y, 65% female, 17% <$20 000/y income. I: Tailored feedback plus self-help. Feedback mailed and included a PCP letter, 2 feedback forms (fat and fiber), and 2 recommendation forms (fat/fiber). Structured telephone counseling within 2 wks to reinforce mailed feedback, address needs of low literate. Low-literacy self-help booklets mailed weekly ×4. A cultural, community advisory board made decisions about content and pictures in intervention material.
C: Delayed intervention.
Fiber: per fat and fiber questionnaire, higher scores=more fiber. I group: 2.24 (0.35) at baseline, 2.07 (37) at 6 mo 2.12 (0.39) at 12 mo vs C group: 2.24 (0.36) at baseline, 2.16 (0.37) at 6 mo, and 2.16 (0.38) at 12 mo.
Fat per questionnaire, lower scores=less dietary fat: I group: 0.2.03 (0.35) at baseline, 1.85 (0.34) at 6 mo, 1.87 (0.35) at 12 mo, vs C group: 2.05 (0.33) at baseline, 1.97 (0.34) at 6 mo, 1.95 (0.34) at 12 mo. For fat and fiber, I group significant improvement over time P<0.05); interaction between condition and time significant P<0.05.
… … …
 Havas et al,48 1998, 2-group randomized crossover design/8 mo and 1 y (N= 3122) Women served by 16 WIC programs in Maryland. 52% black, ≈66% age <30 y, 19% <HS education, approximately 44% using food stamps. I: 3 components—(1) Stage of change-based nutrition sessions conducted by peer educators; (2) printed materials and visual reminders; (3) direct mail. Three peer-led 45-min group discussions over 6-mo period, goal-based. Story-based print materials and videotapes about F/V were used.
C: Intervention delayed.
F/V: Change between baseline and 8 mo, I group +0.56±0.11 servings vs C group +0.13±0.17, between group P= 0.002.
At 1 y, I group added increase of +0.27±0.09 servings vs C group +0.27±0.06 servings; between-group difference, P= 0.004 ES=0.05.
… … …
 Keyserling et al,49 2002, 3-group RCT/12 mo (N=167) 100% women with type 2 DM, 100% black, mean age 59 y, ≈33% income <$10 000/y A. Clinic and community: In clinic—4 monthly visits with a nutritionist who counseled about diet and PA and tailored it to baseline practices and attitudes. In community—3 group sessions and 12 monthly telephone calls from a peer counselor who provided social support and reinforced behavior change goals.
B. Clinic only: Same as clinic described above.
C. Minimal intervention: Educational pamphlets mailed to subjects.
… PA per accelerometer: A vs C groups, the difference in adjusted mean for PA was 44.1 kcal/d, P=0.005. B vs C, the difference was 33.1 kcal/d, P=0.029. … …
 Kumanyika,75 1999, 2-group RCT/1 y (N=330) Black adults recruited from supermarket BP screenings aged 40–70 y. ≈72% female, 47% literacy less than eighth grade 52% <$15 000/y. All subjects to reduce fat, cholesterol, and Na in diet by a nutritionist every 4 mo at office visits. All subjects received some CARDES materials that consisted of (a) food cards with photos of common foods and coded with symbols to indicate low, medium, or high fat, cholesterol, or Na content; (b) a 42-page nutrition guide; (c) 25-min video to motivate and support change; and (d) 12, 10–15-min audiotapes and accompanying worksheets to provide info. CARDES materials were at fifth to eighth grade reading levels.
Full Instruction (F): Subjects participated in monthly nutrition classes for 4 mo after enrollment in which a CARDES video was viewed; guidance provided about audiotapes and worksheets, and discussion of themes in audio programs. Video portrayed African American family.
Self-Help (SH): In addition to counseling every 4 mo, subjects received self-help materials including food cards and nutrition guide.
… … … All NSD between groups. Change from baseline:
Total cholesterol (mmol/L): F −0.41 ±0.07 female, −0.50±0.12 male, P=0.0001, vs SH −0.43±0.07 F, −0.36±0.13 mol/L, P≤0.006.
HDL−C (mmol/L): F 0.3 (0.03) female, 0.01 (0.04) male vs SH −0.02 (0.03) female, −0.03 (0.05) male.
NSD within-group difference. LDL-C (mmol/L): F − 0.34 (0.07) female, −0.36 (0.11) male, within group P<0.001, vs SH −0.35 (0.07) female, −0.31 (0.12) male; within group P≤0.009. SBP (mm Hg): F −7.4 (1.9) vs SH −10.6 (1.9), within-group difference, P=0.0001. DBP (mm Hg): F −3.7 (1.1), P=0.0007 vs SH group −6.6 (1.1), P=0.0001.
 Racette et al,51 2001, quasi-experimental/1 y (N=69) 100% black, employees of the University of Washington medical center at risk for type 2 DM, 86% female, education and income not reported. I: Assigned diet goals (ie, decrease fat ≈14g/d). Subjects received a 1-wk energy- and fat-restricted diet prepared by a metabolic kitchen followed by a lifestyle program and increased PA for 1 year.
Subjects received PA prescription and help about how to meet goals, 7-d food diaries every 4 mo and exercise logbooks. There were: individual meetings on request over 1-y period; optional bimonthly group meetings; monthly telephone calls to maintain contact.
C: Subjects matched for age, body weight, body composition, and glucose tolerance. Subjects were invited to enroll in the intervention on completion of the study.
… … Weight loss: −4.6 kg in I vs + 0.3 kg in C, P<0.001. Total cholesterol (mmol/L): −0.3 in I vs +0.4 in C, P< 0.001.
Glucose tolerance (GT): At baseline 13 in I had impaired GT, and 6 had diabetic GT; at 1 y, 10 had normal GT, 4 had impaired GT, and 5 had diabetic GT. Control: no difference from baseline.
 Resnicow et al,102 2001, cluster randomized trial/12 mo (N=861) 100% black church members, mean age 43.9 y, 73.3% female, «*45% had income >$40 000, >50% had at least some college. A. Comparison: Standard nutrition and culturally sensitive F/V education materials.
B. Self-help+1 cue call: Self-help materials included a video, cookbook, printed education materials, quarterly newsletters, and other cues (magnet, pot-holder, erasable writing tablet). Calls provided cues to use intervention materials.
C. Multicomponent: Multicomponent self-help materials with 1 cue call and 3 motivational interviewing counseling calls.
F/V: Change in F/V was significantly greater in group C vs group A or B. The net difference between group A and C was 1.38, 1.03, and 1.21 servings of F/V per day for the 2-, 7-, and 36-item FFQs, respectively. The net difference between group A and B was 1.14, 1.10, and 0.97. … … …
 Rosal et al,52 2005, 2-group RCT/3 and 6 mo (N=25) Adults with type 2 DM recruited from a community. 100% Hispanic, 80% female, mean age 62.6 y, 84% <$10 000/y, 74% less than or equal to eighth grade. All participants received a booklet describing importance of lifestyle factors in DM and providing recommendations for diet, PA, and SMBG.
I: Initial 1-h individual session plus two 15-min individual sessions, followed by 10 weekly 2.5–3 h group sessions and two 15-min individual sessions on diabetes; tailored to literacy level and culture, included: self-monitoring logs, step counters. A bilingual nurse, nutritionist, and an assistant. Interventionist bilingual and known in community.
C: Subjects only received the booklet received by all participants.
… NSD in increased PA between or within groups. BMI: NSD. HbA1c: decrease at 6 months in I was −0.85% vs −0.12%, P<0.01.
Total cholesterol (mg/dL): −2.0 in I, +11.2 in C at 6 mo, NSD.
LDL (mg/dL): +3.2 in I vs +12.5 in C at 6 mo, NSD.
SBP and DBP: NSD.
 Staten et al,53 Arizona WISEWOMAN, 2004, 3-group RCT/12 mo (N=217) Women recruited from 2 Tucson clinics, mean age 57.2 y, 75% Hispanic, income $9737/y. Active control—provider counseling (AC-PC): At each clinic visit, NPs provided health education brochures, discussed benefits and barriers to increasing PA and F/V, gave behavior change prescription; suggested goals 150+ min/wk of PA and 5+ servings F/V per day.
Provider counseling+health ed classes (PC+HE): Counseling plus subjects referred to 2 education classes on diet and PA; also a monthly health newsletter for 12 mo.
Provider counseling+health education classes+CHW provided social support (PC+HE+CHW): Counseling and health education classes plus subjects received semiweekly to monthly telephone calls from CHWs to provide info regarding benefits of PA and F/V, how to modify behavior, bimonthly walks provided encouragement to find walking partners and support.
F/V: Change at 12 mo, PC+HE+CHW: +0.26±−0.5, 1.0 vs PC+HE —0.23±−1.0, 0.5 vs PC −0.59± −1.2, 0.1, NSD all comparisons.
−7.4% more women who received PC+HE+CHW progressed to eating ≥5 F/V/d than in PC+HE (−8.3%) or PC (−5.2%), P≤0.05, ES=0.07.
PA min/wk: Change from baseline, PC+HE+CHW: +22.8 (6.0, 39.6), P=≤0.01, vs PC+HE: +22.6 (2.2, 43.0), P≤ 0.05, vs PC: +15.1 (0.5, 29.8), P≤0.01, ES=0.03. BMI: Change from baseline, PC+HE+CHW: 0.1 (−0.3, 0.6) vs PC+HE: +0.7 (−0.1, 1.4) vs PC: −0.1 (−0.6,
0.5), NSD all comparisons.
Total cholesterol (mg/dL): Change from baseline, PC+HE+CHW: −8.3 (−16.0, −0.7) vs PC+HE: −10.9 (−19.9, −1.8) p≤ 0.05 vs PC: −6.1 (−13.7, 1.4).
SBP (mm Hg): PC+HE+CHW: −5.1 (−8.9, −1.2) 0.01 NSD in other 2 groups.
DBP (mm Hg): PC+HE+CHW: + 1.3 (−0.8, 3.3) vs PC+HE. 43 (−1.6, 2.5) vs PC+3.4 (1.5, 5.2).
 Stoddard et al,112 2004, MA WISEWOMAN Project, 2-group RCT/12 mo (N = 1443) Women, mean age 58 y, 79% black, 70% with BMI ≥25, all uninsured or underinsured, retention: 80% for EI, 73% for MI. All participants received low-literacy fact sheets on CVD risks, nutrition, and PA; also a follow-up screening at 12 mo.
Minimum Intervention (MI): Subjects received comprehensive CVD risk assessment, on-site counseling, education, referral, and follow-up as needed.
Enhanced Intervention (EI): Subjects received same as MI plus group education, one-on-one dietary and PA counseling, group activities such as walking.
F/V: 80% MI vs 82% EI >5 servings/d, P=0.12. Proportion with increased PA: 6% MI vs 18% EI, P=0.04. … Proportion with normal BP: 73% MI vs 82% EI, P=0.80; normal total cholesterol: 74.6% in MI vs 81% in EI, P=0.63.
 Yancey et al,59 2006, 2-group RCT/2-, 6-, and 12-mo (N = 366) Obese black women attending a black-owned gym. Mean age 45.5 y, income $40 000-$59 000/y. A 1-y gym membership was offered to all participants as an incentive to participate in study.
I: Subjects participated in 8 weekly 2-h interactive group sessions including PA and dietary education promoting low-fat complex CHO rich diet; pedometers and exercise bands provided; dietary recalls done by dietitian 3 or 4 times, provided feedback.
To provide social support, subjects invited to come to gym with a friend. Instructors were culturally/ethnically matched to subjects.
C: Subjects received 8 weekly, 2-h interactive sessions on black women’s health topics without the social support component.
… Fitness, within group: I group and C group fitness levels (per 1-mile run/walk) improved by 1.9 and 2.3 min, respectively at 12 mo. Within group differences, P=0.0001 for both I and C; NSD between groups. Weight (kg): Both groups significantly heavier at 12 mo, P=0.001. …
 Yanek et al,55 2001, 2-group cluster RCT/1 y (N = 59) All black women, mean age 53 y, Income ≈$36 000/y. Note: Ultimately the standard and spiritual interventions operated identically (SI) since women did not believe there could be a church-based program without spirituality.
Standard behavioral intervention (SBI): Subjects attended kick-off retreat for 1.5 days, received feedback on baseline data; also received 20 weekly group sessions on diet and PA focusing on building self-efficacy and skills; each session included weigh-ins, taste tests, cooking demos, and 30 min of moderate-intensity PA. After 20 wks, lay-led weekly sessions provided info/support for rest of year. Church sponsored yearly events.
Spiritual Intervention: Weekly sessions included prayer and health messages enriched with scripture, aerobics to gospel music, or praise and worship dance.
Self-help control intervention (SH): Subjects received AHA materials on healthy eating and PA and information targeted to subjects’ personal screening results.
Energy intake (kcal/d): Change at 1 y, −117 for SI vs −7 for SH. Within group P=0.0001 for SI vs P=0.8190 for SH. Between group P<0.004.
Na (mg/d): −145 in SI vs −8 SH, within group P=0.0001 and between group P=0.02.
Total fat (g/d): Change at 1 y, −8.1 in SI vs −2.3 in SI, within group P=0.0001 for SI and 0.2374 for SH, Btw group P=0.03.
… Weight loss (lb): Change at 1 y, −1.1 SI vs +0.83 in SH, w/group P=0.009 between group P=0.0008. BP (mm Hg): Change at 1 y, SBP −1.6 and DBP −0.36 in SI vs SBP −0.95 and DBP +0.22 in SH; within group P=0.004 for SBP and 0.21 for DBP in SI; NS for SH; NSD between groups.

WIC indicates Women, Infants, and Children; NP, nurse practitioner; and CHO, carbohydrates.