Table 2.

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

Reference(s), Year, Study Design/Duration (N)	Population/Sample	Intervention	Outcomes
			Calories/Fat/Fruits and Vegetables/Fiber/Sodium	PA	Weight	BP/Cholesterol/Glucose/Hemoglobin A1c
Print-only delivery strategies
Hunt et al,118 2004, 2-group RCT/12 mo (N=5473)	Primary care practice subjects with mildly controlled HTN, 58% women, mean age 69 y, ≈90% white. Retention: 52%.	I: 2 educational packets sent 3 mo apart; first focused on HTN and lifestyle, second on medication adherence and home BP monitoring with BP log; both included letter from PCP. Subjects from both groups randomly selected to have BP measured and complete survey. Intervention group scored higher on HTN knowledge quiz (7.48±1.6 vs 7.06±1.6, P=0.019). C: Subjects received usual care.	…	…	…	BP: C 137/77 vs I 135/77, P=0.229.
Marcus et al,79 1998, 2-group RCT/6 mo (N=194)	76% female, mean age 44.3 y, 93.8% white, 82% employed, mean 12.5 min of moderate level PA at baseline.	C: 4 self-help booklets promoting PA mailed to subjects. I: Computer-generated, individually tailored reports and self-help manuals matched to stage of motivational readiness. Reports consisted of feedback about (1) stage of readiness for PA; (2) level of self-efficacy, decisional balance, and use of cognitive-behavioral processes; (3) comparative feedback; and (4) progress since last assessment. Motivationally matched manuals accompanied reports; sent by mail.	…	PA: I group: mean of 97.6 min of PA/wk compared with I group (151.4 min/wk); A significantly greater number of I subjects reached recommended PA than C group.	…	…
Group-based intervention delivery strategies
Aldana et al,113 2006, 2-group RCT/6 mo (N=348)	70% women, mean age 50 y, 93% white, BMI 31–33. Retention: Intervention 88%, control 95%.	I: 40-lecture course over 4 wks, focus on nutrition and PA. Textbook and workbook followed curriculum topics provided, included assignments. Only within-group changes reported, all P values significant. C: Not described.	…	…	Weight loss: C–0.5 vs I–4.5 kg, P<0.0001.	SBP/DBP mm Hg: –5/–5.5 vs –4/–3.8, P=0.0001 Cholesterol: 6 –vs –11, P=0.004 Glucose: –3 vs –1, P=0.005.
Andersen et al,56 1999, 2-group RCT/1 y (N=40)	Women, mean age 43 y; BMI 32.9. Retention: 98% at 16 wks, 82.5% at 68 wks.	Structured aerobic exercise (SAE)+low-fat diet: weekly aerobic exercise classes for 16 wks. Moderate lifestyle activity+low-fat diet: weekly group sessions focused on moderate PA, kept daily records, wore pedometers, received graphs of PA and feedback.	…	…	Weight loss: SAE group –8.3 kg vs –7.9 kg at 16 wks, P=0.08; ES=0.57. At 1 year, SAE regained 1.6 vs 0.08 kg.	SBP, cholesterol improvement within groups (P<0.001) at 16 wks, NSD between groups.
Burke et al,24 2006, 4-group RCT/18 mo (N=182)	87% women, mean age 44 y, 29.7% minority, BMI 34. Retention: 86%.	Standard behavioral weight loss treatment (SBT) delivered to all 4 groups: (1) SBT+lacto-ovo-veg (LOV) diet/not preferred, (2) SBT+LOV diet/preferred, (3) SBT+standard weight loss diet/not preferred, (4) SBT+standard weight loss diet/preferred. SBT includes goal setting, self-monitoring, and feedback. Intervention 12 mo, study gives 6-mo report.	…	…	Weight loss by diet groups: –7.0–7.5 kg, NSD by diet or preference group; ES=0.03.	LDL: SBT 0.05 vs SBTLOV –0.16, P=0.013.
Carels et al,23 2004, 2-group RCT/1 y (N=44)	100% women, mean age 54.7 y, race not reported, 44.5% college degree, 33.3% income <$30 000, mean BMI 36.4.	Lifestyle change (LC): 24 group sessions to change weight and PA; 5 components: lifestyle, exercise, attitudes, relationships, and nutrition. Focused on self-monitoring, controlling stimuli, PA, nutrition education, modifying self-defeating thoughts and negative emotions, setting realistic goals, relationships, relapse prevention, and weight maintenance. Lifestyle change+self-control skills training: Lifestyle change as above plus a combination of didactic instruction, individual activities, and weekly out-of-class assignments to strengthen self-control.	Calories: Average daily caloric intake decreased 472 cal in both groups, P<0.05. Percent of energy from fat and saturated fat decreased by 5.4% and 2.7%, respectively; P<0.05. NSD between groups.	PA and fitness: both groups increased maximal oxygen consumption, treadmill time, and weekly leisure time activity P<0.05. NSD between groups.	Weight loss: Mean weight loss in both groups was 6.2 kg, P<0.05. NSD between groups.	BP: Both groups had a mean decrease in SBP of 8 mm Hg and in DBP of 7.9 mm Hg, P<0.05. NSD between groups. Chol: For both groups LDL decreased an average of 10.6 mg/dL. NSD between groups.
Heshka et al,123,124 2003, 2-group, multicenter RCT/2 y (N=423)	>80% women, age 44–45 y, BMI 34.	Self-help program (SH): two 20-min counseling sessions with nutritionist and provision of self-help resources. Commercial weight loss program: food and activity plans, cognitive restructuring behavior modification plan, weekly meetings over 104 wks.	…	…	Weight loss: SH group –1.3 vs Commercial group –4.3 kg, P<0.001 at 12 mo; –0.2 vs –2.9 kg at 2 y, P<0.001; ES=0.16.	…
Jakicic et al,109 1999, 3-group RCT/18 mo (N=148)	Women, mean age 37 y, BMI 32.8. Retention: 78%.	Behavioral weight control program combined with (1) Long-bout exercise (LB); (2) multiple short-bout exercise (SB); or (3) multiple short-bout exercise with home exercise equipment (SBEQ) (provided treadmill).	…	VO2 significantly increased compared with baseline, NSD among groups.	Weight loss in SBEQ –7.4 kg vs SB –3.7, P<0.05; NSD from LB group –5.8; ES=16.	…
Jeffery et al,25 1998, 5-group RCT/18 mo (N=193)	≈80% female, age ≈40 y, ≈80% white, BMI 31. Retention: 78%.	(1) Standard behavioral therapy for weight loss (SBT); (2) SBT+supervised walks (SW) 3/wk; (3) SBT+SW+personal trainer (PT) worked with 2–3 subjects during walks; (4) SBT+SWmonetary incentives (I) paid $1–$5 for walks (In); and (5) SBT+SW+PT+In received all of the above. SBT=weekly group sessions ×24, monthly thereafter for 1 y. Daily calorie/fat goals, PA 250–1000 kcal/wk.	…	PA: subjects in all groups achieved study goal of 1000 kcal/wk.	Weight loss in kg: SBT –7.6 vs SBT+SW –3.8 vs SBT+SW+PT 2.9 vs SBT+SWI –4.5 vs SBT+SW+PT–I 5.1 kg, Treatment groups difference from baseline to 18 mo was significant, P<0.03. The SBT group had greater losses.	…
Writing Group of the PREMIER Collaborative Research Group,26 2003, 3-group RCT/6 mo (N=810)	Adults with stage 1 hypertension or optimal BP, 34% black, 62% women, mean age 50 years, approximately 10% <$30 000 annual income.	Subjects’ goals for EST and ESTDASH were weight loss ≥15 lb for subjects with BMI ≥25, ≥180 minutes/wk moderate intensity PA, daily intake of ≤100 mEq Na, daily intake ≤1 oz alcohol for men and ½ oz for women. Established (EST): 18 face-to-face contacts (14 group meetings and 4 individual sessions). Diaries used to record PA, calories, and Na. Established plus DASH (EST+DASH): Subjects received all in EST plus instruction and counseling about DASH diet; dietary goals for F/V, low-fat dairy, saturated fat, and total fat. Diaries used to record PA, calorie, Na, F/V, dairy, and fat. Advice only (A): Dietitian provided a 30-min individual session on nonpharmacological factors that affect BP and provided printed educational materials. Counseling on behavior change not provided but had 4 individual counseling sessions on lifestyle change. DASH diet included 9–12 servings F/V per day, low-fat dairy 2–3 servings/d, <7% energy saturated fat, and <25% energy total fat.	F/V servings/d: Change from baseline, 0.5 for A, 0.5 for EST, 3.0 for ESTDASH. EST vs A, P<0.79; all other comparisons P0.001. Total fat, % kcal: –1.0 for A, –3.9 for EST, –9.5 EST+DASH. All comparisons P<0.001.	PA kcal/kg/d: NSD.	Weight loss: Change from baseline: 1.1 kg in A, –4.9 kg in EST, –5.8 kg in EST+DASH; EST vs A and EST+DASH vs A, P=0.001; EST vs ESTDASH, P=0.07.	Prevalence of high BP at 6 mo: 26% in A group, 17% in EST group, 12% in EST+DASH group (difference between A and EST, P=0.01; between A and EST+DASH, P=0.001; between EST and EST+DASH, P=0.12).
McManus et al,27 2001, 2-group RCT/18 mo (N101)	≈90% female, mean age 44 y, ≈88% white, BMI 34. Retention: 20% vs 54% at 18 mo.	Low-fat (LF) diet: 20% of kcal. Moderate fat (MF): 35% of kcal, Mediterranean diet. Both groups: weekly group educational classes to address behavioral modification skills and PA; self-monitored in weekly diaries, feedback provided.	Total fat (% kcal): LF 30% vs MF 35%, P=0.03.	…	Weight loss: LF –2.9 vs MF –4.8 kg at 18 mo, P<0.001; ES0.33.	…
Simkin-Silverman et al,66 2003, 2-group RCT/4.5 y (N=535)	Women (peri- to postmenopausal), predominantly white, 35.5% overweight, 11% obese. Retention at 5 y: 95%.	C: Health education pamphlet and assessment only at 6, 18, 30, 42, and 54 mo. Lifestyle intervention (LI): Phase 1: 15 group meetings/20 wks, lifestyle changes, modest weight loss, and PA; Phase 2: 6 group meetings in mo 6–54; mail and telephone F/U. Individual nutrition consultation offered to lower LDL cholesterol.	Kcal: C –24.8 vs LI –159.6 kcal, P<0.01; ES0.11.	Energy expenditure: C –113.3 vs 274.9 kcal, P<0.001; ES=0.14.	Weight loss: 55% of LI group were at or below baseline weight compared with 26% of C group, P<0.001. Mean weight change in LI group was 0.1 kg below baseline compared with mean weight gain of 2.4 kg in C group.	…
Toobert et al,67 2005, 2-group RCT/6 mo (N=279)	Postmenopausal women with type 2 DM, 90% white, BMI 35. Retention: 88%.	UC: ongoing diabetes care from MD Mediterranean Lifestyle Program (MLP): lifestyle change aimed at behavioral risk factors affecting CHD; 2.5-d retreat followed by weekly 4-h meetings for 6 mo. Focus: diet, PA, stress management, social support.	Total fat (g): UC 162.1 vs MLP 46.6 g, P<0.001; ES=20. Fruit servings/d: UC 1.6 vs 2.2, P<0.001 Vegetable servings/d: UC 2.0 vs 2.6, P<0.001.	PA (METs×duration×days): 55.9 UC vs 80.9 MLP, P<0.009.	Weight: UC 93.4 vs MLP 91.7 kg, P<0.004.	…
Wadden et al,72 1998, 4-group RCT/1 y (N=99)	Women, mean age 42 y, BMI 36. Retention: 60.2%.	Cognitive-behavioral treatment for weight loss delivered in 28 weekly sessions followed by 10 biweekly sessions combined with caloric-restricted diet plus 1 of 4 exercise groups: (1) aerobic exercise, (2) strength training+aerobic, (3) strength training, or (4) no exercise beyond lifestyle activity.	…	…	Weight loss: 4 groups 10.6–11.4 kg, NSD; at 1 y 35%–55% of weight regained, NSD.	…
Wadden et al,28 2005, 4-group RCT/1 y (N=224)	Men & women, mean age 43.6 y, 65% white, BMI 37.8.	All subjects had diet of 1200–1500 kcal/d and exercise 30 min/d most days of the week. Sibutramine Alone (Sib A): 8 brief visits with PCP at 1, 3, 6, 10, 18, 40, 52 wks. Received dose of sibutramine at wk 1; received print materials about fitness. Lifestyle Modification Alone (LMA): Wkly group meetings from wks 1–19, every 2 wks from wks 20–40, follow-up visit wk 52. Daily self-monitoring of food intake and PA, which were reviewed at wkly meetings. Combined Therapy (CT): Same 2 treatments as groups above. Sibutramine plus Brief Therapy. (SibBT): Sibutramine as in group 1 and met with PCP 10–15 min. on same schedule as group meetings.	…	…	Weight loss: CT 12.1±9.8 kg vs SibA 5.0±7.4 kg vs LMA 6.7±7.9 kg vs SibBT, 7.5±8.0 kg, P<0.001. Subjects in CT group who self-monitored frequently: weight loss 18.19.8 kg vs 7.7±7.5 kg, P0.04.	…
Wing et al,29 1999, 4-group RCT/10 mo (N166)	Women and men, age ≈42 y, 90% white, BMI 31.2. Retention: 75%–95%.	(1) Recruited alone and standard behavioral therapy for weight loss SBT; (2) recruited alone and SBT+social support; (3) recruited with friends and SBT; (4) recruited with friends & SBTsocial support. SBT includes group sessions; self-monitoring calories, fat, and PA in weekly diaries; and feedback. Social support: included intragroup activities and intergroup competition for groups 2 and 4.	…	…	Weight loss: Recruited with friends −7.7 kg, recruited alone −4.3 kg, P<0.001; ES=0.26.	…
Yeh et al,68 2003, 2-group RCT/2 y (N=80)	Women, age 30–60 y, BMI 36.3 and 37.9. Retention: 33% SBI, 35% CB.	Office-based counseling with dietitian (OBC): 6 intervention sessions over 6 mooffer of 6 more. Skills based intervention (SBI): two 90-min didactic sessions related to diet and behavior; additional sessions for technical skill building (supermarket, restaurants); telephone and E-mail access to dietitian for rest of 12 mo.	Saturated fat (g): OBC −0.08 vs SBI −4.2 g at 24 mo, P=0.07.	…	Weight loss: OBC −4.0 vs SBI −1.7 at 6 mo, P<0.05; 1.1 vs −0.6 at 24 mo. NS.
Individual-based intervention delivery strategies
Ammerman et al,98 2003, 2-group cluster randomized trial, 8 rural health departments/12 mo (N=468)	71% female, mean age 55 y, 80% white, 75% HS education.	Subjects in both groups were informed of cholesterol results by letter; if lipids high, they were informed they needed treatment. Special intervention (SI): (1) Public health nurse directed component using Food for Health Program during 3 counseling visits; (2) referral to a local nutritionist if lipids remained elevated at 3 mo F/U; (3) a reinforcement program during 2nd half of intervention—1 telephone call from nurse and 2 newsletters. Structured, individually tailored dietary counseling by nurse facilitated by a dietary risk assessment, illustrated goal sheets, and a Southern style cookbook. Minimal intervention (MI): Other than initial letter about cholesterol results, other intervention activities not described.	Dietary Risk Assessment Score 2.1 units better in the SI vs MI, P=0.005.	…	NSD in weight loss.	Reduction in total cholesterol similar in both groups: 18.4 mg/dL in SI vs 15.6 mg/dL in MI, P=0.06.
Burke et al,30 2005, 2-group RCT/14 wks (N65)	60% male, 94% white, BMI 38–45. Retention: 98%.	UC: Usual clinical care. I: Telephone-delivered, self-efficacy–based counseling to improve adherence to a cholesterol-lowering diet, 6 sessions over 12 wks, included goal setting, self-monitoring with feedback, self-efficacy enhancement.	Fat change score: UC 2.3 vs I −10.4 g P=0.035; ES=0.29. Saturated fat change score: UC 0.18 vs I −23 g, P=0.045; ES=0.28.	…	…	LDL-C change score: UC 0.25 vs I 0.42 mg/dL, P=0.013; ES=0.30.
Delichatsios et al,130 2001, 2-group cluster randomized trial/3 mo (N=504)	70% female, 91% white, mean age 54 y.	C: Usual PCP practice I: 3 components—personalized diet recommendations and stage-matched diet-related educational booklets by mail, provider endorsement of the recommendations, and 2 motivational interview counseling sessions by telephone. Counseling encouraged goal-setting and stage of change messages.	F/V: Change in F/V intake in I group was 0.6 (CI, 0.3–0.8) servings/d higher than control group.	…	…	…
Elliot et al,71 2007, 3-group cluster randomized trial/12 mo (N599)	97% male firefighters, mean age 41 y, 91% white, income ≥$50 000.	Both intervention groups received a Health and Fitness guide. Team centered: Work groups with designated leader met for 11 45-min sessions and followed scripted lesson plans on nutrition, PA, energy balance, stress, sleep, and dietary supplements. Members received baseline PA, dietary, and lab assessment results followed by goal setting. Motivational Interviewing (MI): Participants randomly assigned to 1 of 6 MI counselors; 4 meetings with MI counselor with possibility of 5 hours of additional in person or telephone contact. Control: Received only test results with explanation of normal values; free to use own initiative to alter lifestyle.	F/V: Both Team and MI had increased F/V intake (P<0.05).	PA: Team and MI increased no. of sit-ups in 1 min, P<0.05.	Weight: Both Team and MI gained weight, but less gain than UC, P<0.05.
Keyserling et al,227 2-group RCT, randomization of clinician-patient groups/1 y (N=372)	42 physicians, ≈66% patient participants with high cholesterol were female, 40% black, 11% Native American, Mean age 55.9 y, 10.6 mean y education.	I: 3 components—(1) clinician-directed dietary component; (2) referral to a local dietitian if LDL-C remained elevated at 4 mo follow-up with ≥2 risk factors or CHD; (3) a prompt for the clinician to consider drug treatment based on LDL-C at 7 mo follow-up. UC: Physicians were advised to manage their subjects hypercholesterolemia according to their usual practices.	…	…	…	Total cholesterol: At 4-mo follow-up, total cholesterol decreased 0.33 mmol/L in the I group vs −0.21 mmol/L in the C group (90% CI, 0.02–0.24 mmol/L). The mean reduction at 1-y follow-up was 0.09 greater in the I group (90% CI, −0.01–0.19 mmol/L). Changes in LDL-C were similar.
Marcus et al,69 2007, 3-group RCT/12 mo (N=239)	82% female, 90.3% white, mean age 44.5 y, mean BMI 28.5, 60% with household income >$50 000.	C: Health education material mailed on same schedule as print and telephone; subjects completed PA log each month. Telephone (T): Subjects received PA intervention materials through telephone contact with a health educator. Educator incorporated individually tailored feedback generated by an expert computer system and provided counseling using a motivation staged-matched manual. Mean length of calls was 13 min; 90% of calls were completed, 14 contacts over the course of 12 mo. Completed PA log each month. Print (P): Subjects received individually tailored printed reports of PA, feedback generated by expert computer system, along with manuals matched to their stage of readiness and tip sheets, 14 contacts. Completed PA log each month.	…	PA: At 6 mo, subjects in T group (123.3±97.6) and P group (129.5±156.5) reported larger increase in min of PA/wk than subjects in C group (M77.±7101.89), P=0.02. At 12 mo, P group reported greater moderate-intensity PA compared with C group, NSD between T and P groups.	…	…
Green et al,31 2002, 2-group RCT/6 mo (N=316)	52.5% female, 91.5% white, median age 44.5 y.	UC: No telephone calls. I: 3 20–30 min telephone calls monthly for 3 mo from behavioral health specialists who provided motivational counseling in accordance with stages-of-change model, goal setting, assistance with problem-solving barriers, and identify resources for support.	…	PA: Higher PA level per PACE score for I 5.37 vs 4.98 in UC, P<0.05.	…	…
Ornish et al,222 1998, 2-group randomized invitational design/5 y (N=35)	91% male with moderate to severe CHD, Mean age 59.6 y, mean 15 y of education.	I: Intensive lifestyle change, 10% fat, vegetarian diet, aerobic exercise, stress management, smoking cessation, group psychosocial support for 5 years. C: Follow advice of physician regarding lifestyle changes.	Fat intake: I group fat intake decreased 30% to 8.5%, P<0.001; dietary cholesterol decreased 211 to 18.6 mg/d, P=0.002 C group decreased fat intake 30% to 25%.	…	Weight: I group 12.8 lb loss vs no change in C group, P<0.001.	LDL-C: I group decreases 20% vs 19.3% in C group, NSD between groups. Arterial stenosis decreased from baseline in I group, P=0.001 between groups.
Ockene et al,95 1999, 3-group RCT/1 y	927 primary care subjects, 45 primary care internists. 66% female, 90% white, BMI 29. Retention not reported.	UC: Usual clinical care in primary care setting. Physician nutrition counseling training: 2 sessions, a 2.5-h small group session and a 30-min individualized tutorial; included didactic instruction, videotape observation, and role-playing. Physician nutrition counseling trainingoffice-support program: As aboveoffice-support program designed to assist MD in carrying out counseling sequence, eg, patient completed Dietary Risk Assessment in waiting room, lipid results flagged. Note: counseling took 8.2 min, 5.5 min more than control condition.	Fat %kcal: Group 1 vs 2 vs 3 −0.7% vs −1.0% vs −2.3%, P=0.11. Saturated fat (% kcal): 0.0 vs 0.4 vs −1.1%, P=0.01; ES=0.10.	…	Weight loss: Group 1 vs 2 vs 3 0.0 vs −1.0 vs −2.3 kg, P<0.001.	LDL-C: −0.01 vs −0.02 vs −0.11 mmol/L, P=0.10. Total cholesterol: HDL ratio: 0.1 vs 0.1 vs −0.1 mg/dL, P=0.004.
Pinto et al,125 2005, 2 group/6 mo (N=100)	85% white, 63% female BMI 29. Retention: EA 46, BA 44.	Brief advice (BA): Brief advice to exercise by a clinician alone. Extended advice (EA): Brief advice to exercise from a clinician supplemented by telephone-based counseling by health educators, counseling tailored to subject’s readiness to increase PA levels as well as their conviction and confidence; used motivational interviewing techniques.	…	Energy expenditure: BA 0.83 vs EA 3.8 kcal/wk 3 mo, P=0.03; ES=0.23; 6 mo, P=0.05, ES=0.20.	…	…
Richards et al,104 2006, 2-group RCT/4 mo (N=437)	100% college students; mean age 20.4 y, 75% women, 96% white.	I: Subjects received a personalized letter to stage of change, a series of 4 stage-based newsletters specific to their stage of change at baseline, 1 motivational interviewing session, referral to a nutrition Web site, and a minimum of 2 E-mail contacts over a 4-mo period. C: Subjects completed baseline and following surveys with no additional contact from study personnel.	F/V: Consumption increased by 1 serving.d in I group as measured by a 26-item FFQ and a 1-item FFQ vs 0.4 servings/d in C group per the 1-item FFQ and no change per the 26-item FFQ.	…	…	…
Stevens et al,32 2003, 2-group RCT/12 mo (N=616)	Women, mean age 54.4 y, 91% white, BMI 30.2±7.1. Retention I: 89%, Con: 85%.	C: Focused on breast self-examination, individual session+videotape, and 2 F/U telephone calls. I: Two 45-min diet counseling sessions2 brief F/U telephone contacts, with goal setting, feedback, problem-solving, and motivational interviewing strategies; delivered by master’s prepared health counselors.	Fat (%): C 38.6% vs 34.9%, P=0.001 F/V (servings): C 3.4 vs 4.3, P=0.001; ES0.13.	…	…	…
Computer/Internet-based intervention delivery strategies
Anderson et al,33 2001, 2-group RCT/6 mo (N=277)	96% female, 96% white, median income ≈$35 000.	C: No exposure to supermarket kiosks. I: Subjects used supermarket kiosk-based self-administered, computer-based SCT intervention; provided personalized info, behavioral strategies, incentives for change, and feedback on personal goals. Program guide increase fiber, F/V, and reduced fat in food purchases through 15 weekly segments; offered food coupons of $8–$12/wk.	Fat, fiber, F/V: I group more likely than C group to attain goals for fat, fiber, F/V.	…	…	…
Delichatsios et al,17 2001, 2-group RCT/6 mo (N=298)	72% female, 45% white, 45% black, mean age 45.95 y, BMI 28.7, 85% employed.	C: Used an interactive, computer-based system to serve as an at-home monitor, educator, and counselor regarding diet. Subjects called system 1/wk for 6 mo; received reminder call if subject did not call system in 2 wks. I: Used same system as C except conversation focused on PA.	F/V: I group raised no. of servings of fruit compared with C group (CI, 4–1.7). No differences for vegetables. Dietary fiber raised by 4.0 g/d compared with C group (CI, 1–7.8).	…	…	…
Gold et al,122 2007, 2-group RCT/12 mo (N=124)	98% women, 98% white, age 47 y, BMI 32. Retention: 65% in VTrim, 77% in eDiets.	VTrim: Access to therapist-led structured behavioral weight loss program delivered online. eDiets.com: Access to self-help commercial weight loss program Web site.	…	…	Weight loss: VTrim −8.3 kg vs eDiet −4.1 kg at 6 mos, P=0.004, ES=0.21; at 12 mo, −7.8 vs 3.4, P=0.002, ES=0.16.	…
Marcus et al,108 2007, 3-group RCT/12 mo (N=249)	83.7% female, mean age44.5±9.3 y, BMI 29.4. Retention: 87.1%.	Tailored Internet: Motivationally tailored Internet materials. Tailored print: Motivationally tailored print materials. Researcher-selected Web sites: available to the public.	…	PA (min): NSD among 3 groups; within group increase at 6 mo (5.2%), 12 mo (5.9%).	…	…
Napolitano et al,34 2003, 2-group RCT (N=65)	86% women, mean age 42.8 y, 91% white, 55% $50 000 income/y, BMI 26.4. 88% retention 3 mo.	C: Received I after 3-mo wait. I: Received access to Web site for 3 mo along with weekly E-mail tip sheets. Web site based on SCT, targeted stages of motivational readiness, and provided PA information to help reach goal (eg, use of social support, rewards, planning in activity).	…	PA: At 1 mo, subjects in I group had higher levels of moderate min/wk and walking min/wk vs C group (P<0.05, 0.001, respectively); At 3 mo, only walking min were higher compared with C group (P<0.05).	…	…
Micco et al,35 2007, 2-group RCT/12 mo (N=123)	83% female, 96% white, mean age 46.8 y, BMI 31.7, 74% with college degrees.	Internet: 12-mo SBT weight loss program taught through series of online lessons. Subjects met weekly in online chat rooms. Homework assignments submitted electronically before meeting. Prescribed diet of 1200–2100 cal/d. Emphasized diet abundant in F/V and whole grains and moderate in fat, sugar, and salt; emphasized exercising 5–7 days/wk. Online meetings addressed self-monitoring and setting calorie and PA goals; journals provided basis for feedback. Internet plus in-person: Subjects received same Internet program plus met once a month as a group in person. In-person meetings took the place of online chat sessions, led by different facilitator (dietitian) than online chats.	…	…	Weight loss: No significant group×time difference in weight loss at 6 or 12 mo. Completers lost mean 7.5±6.4 kg at 6 mo and 6.6±6.6 kg over 12 mo.	…
Pinto et al,132 2002, 2-group RCT/6 mo (N=298)	72% female, 45% white, mean age 45.9 y, BMI 28–30. Retention: TLC-PA 75%, TLC-Eat 89%.	Telephone-linked communication (TLC)-Eat: Promoted healthy eating, comparison group. TLC-PA: Promoted regular moderate intensity (MI) PA; TLC computer technology, and digitized human speech to converse through totally automated telephone conversations.	NSD	Energy expenditure: TLC-E 2.0 vs TLC-PA 2.3 kcal/kg/d at 3 mo, P=0.02; ES=0.23; NSD at 6 mo, ES=0.02.	…	…
Tate et al,36 2003, 2-group RCT/1 y (N92)	90% female, 89% white, BMI 33. Retention: 85%.	All subjects attended group session: oriented to Internet; instructed on calorie, fat restriction, PA goals; how to self-monitor. Basic Internet (BI): Web site tutorial on weight loss, weekly tip and link, directory of Internet resources, weekly E-mail reminder to submit weight and given weight loss info. Internet weight loss program+behavioral E-counseling (IBe): E-mail communication with counselor, submit calorie/fat intake, PA on Web-based diary daily for 1 mo, daily or weekly for 11 mo; weekly counselor E-mail gave feedback.	Fat (% kcal): −1% in BI group vs −4% in I+Be, P=0.06.	Increases in energy expenditure: +63 in BI vs +342 kcal in I+Be, P=0.26.	Weight loss: BI −2.0 kg vs 4.4 kg in I+Be, P=0.04; ES=0.21.	…
Tate et al,57 2006, 3-group RCT/6 mo (N+192)	80%, ≥90% white, BMI 33. Retention: 82% at 3 mo, 80% at 6 mo.	All subjects received 1 group session, meal replacement coupons, access to an interactive Web site. No counseling (NC) Computer-automated feedback (AF): Access to electronic diary for self-monitoring foods, PA, weight; message board; weekly: E-mail reminder to self-monitor, behavioral lesson, and feedback from preprogrammed computer. Human E-mail Counseling (HC): AF except feedback delivered via E-mail from human weight loss counselor.	Kcal: NSD Fat intake (%/d): NC 37.2 vs AF 34.0 vs HC 33.1%/d, P=0.004.	NSD	Weight loss: NC −2.6 vs AF −4.9 vs HC −7.2 kg, P=0.001; ES=0.29.	…
Wylie-Rosett et al,37 2001, 3-group RCT/12 mo (N=588 from HMO)	82% female, mean age 52 y, 83% white, 84% ≥1 y of college, mean BMI 35.6. Retention: 81%.	3 incremental levels of weight loss intervention intensity: (1) Workbook alone (W); (2) addition of computerized tailoring using on-site computer screens with touchscreen monitors (W+C); (3) addition of both computers and staff consultation (ie, 6 closed-group sessions and up to 18 telephone or in-person consultations). (W+C+S). All 3 interventions used cognitive behavioral approach for tailoring goals and principles of transtheoretical model of behavioral change.	Mean energy intake and percent energy from fat decreased from baseline in all 3 groups (P<0.01). NSD in mean nutrient intake by group.	All groups reported a mean increase in walking time and number of blocks walked each day (P<0.01). NSD by intervention group.	All groups lost weight. W+C+S lost significantly more weight than W only, P=0.02. W+C did not lose was significantly greater weight than W only.	…
Multicomponent intervention delivery strategies
Carels et al,15 2007, RCT/6 mo (N=55)	87% women, obese adults, 94% white, BMI not provided. Retention: 79–81%.	Behavior weight loss program (BWLP): 20 sessions based on LEARN program. BWLP+stepped care (SC): Individuals in the BWLP+SC group who did not meet weight loss goal received motivational interviewing strategies (MI).	Total calories: BWLP 380 kcal vs BWLP+SC −358 kcal, ES0.11 (P values not reported).	VO2 BWLP+2.3 vs BWLP+SC +1.7, ES=0.12.	Weight loss: BWLP −2.1 vs BWLP+SC −4.5, ES=0.84.	…
Cook et al,221 2007, long-term follow-up 10–15 y after TOHP I and TOHP II trials (N=744 in TOHP I; N=2382 TOPH II)	Across both trials: 68.5% men, ≈78% white, ≈17% black, mean age 43.3 y, mean BMI=29.	TOHP trial: Tested nonpharmacological interventions (ie, weight loss, Na reduction, stress management, and nutritional supplements) in reducing BP in subjects with high normal BP. Of 2182 TOHP I subjects, 327 were randomized to Na+ reduction and 417 were assigned to UC. Individual and weekly group sessions offered for 3 mo; lifestyle interventions were offered for 18 mo. Compared with UC, Na +and BP significantly decreased. TOPH II: Tested the effects of weight loss and Na +on incident hypertension and BP over 3–4 years. 2×2 factorial design. The Na +reduction only group had significantly lower Na+ excretion with corresponding significant decrease in SBP.	…	…	…	CVD: Risk of a CVD event (MI, stroke, CV revascularization or CV death) was 25% lower among those in intervention group, adjusted for trial, clinic, age, sex, and race; risk was 30% lower after further adjustment for baseline Na+ excretion and weight.
Diabetes Prevention Program Research Group,38,228 2004, 3-group RCT/average 2.8 y (N=3234)	ILI group was 68% female, 46.3% minority, BMI 34. Retention: 92.5%	Standard: standard lifestyle placebo group Metformin: 850 mg twice daily. Intensive Lifestyle Intervention (ILI): Main goal: lose 7% of baseline weight and achieve 150 min/wk of PA; individual case manager for full time of study—16 sessions in core curriculum covered basic skills related to nutrition, exercise, and behavior change. Diet ≤25% fat+calorie restriction. Self-monitored min of PA and fat g consumed every day during core curriculum, then 1 wk/mo remainder of trial. Note: Incidence of diabetes reduced significantly greater in the ILI group than in the standard and metformin groups.	For ILL group: Kcal/d: −452 at 1 y Total fat/d (g): −30.3 at 1 y % of cal from fat: −6.6% at 1 y.	PA (METS): +6.6 at 1 y, +4.3 METS at 3 y.	Weight loss: −4.2 kg in ILI group vs 0.8 kg in standard group, P<0.05 at 12 mo. In ILL, −4.1 kg at 3 y.	…
Glasgow et al,39 1997, 2-group RCT/12 mo (N=206)	Adults with DM, 60% female, mean age 62 y, 77% overweight or obese, race not reported. Retention: Intervention: 83.3%; UC: 84.7%.	UC: Quarterly medical care and F/U of risk factor+stouch-screen computer assessment in medical office. Brief Intervention (BI): Single session, touch-screen computer–assisted assessment, immediate feedback on key barriers to dietary self-management, goal setting, and problem-solving counseling; additional video intervention based on self-efficacy score (85 vs ≤85). Telephone calls/videotapes 1 and 3 wks; intervention repeated at 3 mo; telephone call at 6 mo, DM book at 12 mo.	Kcal: UC 1659 vs BI 1547 kcal, P=0.05; ES=0.14 Fat (%): UC 32.0% vs 30.5%, P=0.023; ES=0.16.	…	BMI: NSD.	Cholesterol: UC 226 vs BI 208, P=0.002 HbA1c, NSD.
Glasgow,80 2000, 2×2 Factorial RCT/6 mo (N=320)	Adults with type 2 DM, mean age 59 y, BMI not reported. Retention: 84%–94% for 4 groups.	Subjects received Basic Intervention (BI): health counselor meeting, dietary goals set with aid of touch-screen computer, feedback on dietary pattern. Tailored dietary fat reduction goal. 4 groups: (1) BI; (2) BI+TF (3–4 telephone follow-up calls/6 mo for ongoing support, reinforcement, and problem-solving); (3) BI+Community Resources (CR) Enhancement; (4) Combined Conditions. CR Enhancement: binder of resources, 4 newsletters, goal setting, and FFQ completed/given tailored feedback.	Fat: NSD; ES=0.19. Fat/fiber behaviors: TF groups better, P=0.017.	…	NSD	Cholesterol: CR×phase P=0.010 HbA1c, NSD
Howard et al,58 2006, WHI: Dietary Modification Trial 2-group RCT/7.5 y (N48 835)	Postmenopausal women, 81% white, BMI 29. Retention: 96%.	C: Usual diet, received diet-related education materials (Dietary Guidelines for Americans) I: Group (18 sessions in first year, 4/y afterward) and individual sessions to promote decrease in fat intake, increase in F/V and grain intake; maintain usual energy intake (no weight loss or calorie restriction goals). Three individual sessions that used reflective listening. Self-monitored dietary fat, F/V, grain intake throughout study.	Kcal: C vs I: −240.8 vs −361.4, P<0.001; ES=0.02 % fat: −0.6 vs −8.8% P0.001 F/V: 0.2 vs 1.4 servings, P<0.001 Fiber: −0.2 vs −2.2, P<0.001.	PA (METS): Con vs I 0.9 vs 1.1 METs, P=0.07.	Weight change difference C and I groups at 12 mo, 1.9 kg, P<0.001; at 7 y, 0.4 kg, P=0.01.	…
Look AHEAD Research Group,111 2007, 2-group RCT/12 mo (N=5145)	Adults with T2DM, 59% female, 63% white, mean age 59 y, BMI 35–36. Retention at 1 y: ≈96%	Diabetes support and education condition (DSE): 4 sessions on topics related to diet and PA, no counseling, not weighed. Intensive lifestyle intervention (ILI): Group and individual meetings to achieve/maintain 7% weight loss via decreased caloric intake (30% fat) and portion-controlled diets; increased PA (175 min/wk); 3 group meetings+1 individual meeting monthly during mo 1–6, 2 group meetings+1 individual meeting monthly for 7–12 mo.	…	Cardiorespiratory fitness: Fitness increases 10.8% in DSE vs 15.9% in ILI, P<0.001.	Weight loss: 0.7% vs 8.6% of initial body weight, P<0.0001.	DSE vs ILI: SBP −2.8 vs −6.8, P<0.001; DBP −1.8 vs 3.0, P<0.001; HDL 1.4 vs 3.4, P<0.001; glucose −7.2 vs 21.5, P<0.001.
Perry et al,40 2007, 2-group RCT/12 wk (N=46)	100% rural women, 95% white, mean age 45 y, mean education=15 y.	HTH: Individual+group components. Individual component included motivational interviewing for 30 min at baseline followed by weekly 10-min booster calls. Women asked to set goals and monitor progress and received individualized exercise prescription. Group component included a nurse led 1-h weekly group walk to promote support and self-efficacy. Comparison: Subjects received a brief 10-min individual private advice session, a monthly 5-min reinforcement call, an individualized exercise prescription, and a logbook to record walking.	…	Cardiorespiratory fitness per distance walked in 12-min walk test: Women in HTH had greater improvement in fitness, P=0.057 vs comparison group.	…	…
Stevens et al,41 2001, 4-group RCT (TOHP II)/36 mo (N=1191)	66% male, mean age 43 years, 79% white; BMI 31. Retention: 92% and 93% for weight loss, 89% and 86% for BP measure.	UC: Not described. Weight loss intervention (WLI): Individual counseling followed by 14 weekly group meetings; thereafter, 6 biweekly group meetings. After 18 mo, options included individual or group sessions on selected weight-loss topics. Focus on behavioral self-management, social support; included self-monitoring, goal setting, developing action plans, and problem solving. Weight loss goal of ≈4.5 kg, PA 30–45 minutes, 4–5/wk.	…	…	Weight loss: UC vs WLI: −0.1 vs −4.4, −0.7 vs −2.0, and 1.8 vs −0.2 kg at 6, 18, 36 mo, P<001; ES=0.10.	Difference in scores: SBP −3.7, −1.8, −1.3 mm Hg at 6, 18, 36 mo, P<0.01. DBP −2.7, −3.5, −2.0 mm Hg at 6, 18, 36 mo. P<0.001–0.05; P<0.001–P<0.05.
Writing Group for Activity Counseling Trial,135 2001, RCT/24 mo (N=874)	55% males, mean age 51 y, >60% white; BMI 29–30. Retention: 91.4% completed PA, 77.6% VO2 max.	Advice (AD): Includes physician advice and written educational materials (recommended care). Assistance (AS): Components of AD group+interactive mail and behavioral counseling at physician visits. Counseling (Coun): All of AD and AS components+regular telephone counseling and behavioral classes.	…	VO2 max: Significantly higher in AS than AD group (80.8 mL), higher in Coun than in AD group (73.9 mL); NSD in men; ES=0.07–0.08.	…	…

RCT indicates randomized controlled trial; I, intervention group; BP, blood pressure; PCP, primary care provider; C, control or comparison group; SBP, systolic blood pressure; DBP, diastolic blood pressure; NSD, no significant difference; ES, effect size; LDL-C, low-density lipoprotein cholesterol; F/U, follow-up; DM, diabetes mellitus; UC, usual care; METs, metabolic equivalents; HS, high school; F/V, fruits and vegetables; HDL, high-density lipoprotein; FFQ, Food Frequency Questionnaire; SCT, social cognitive theory; HMO, health maintenance organization; CVD, cardiovascular disease; and Hb, hemoglobin.