| Study, Year | Intervention | Intervention Setting | Intervention Delivery | Counseling and Behavioral Description |
|---|---|---|---|---|
| Stevens et al, 200170 | Control | Not noted | Not noted | Usual care (details not noted). |
| Weight loss only | Not noted | Dietitians or health educators | One individual counseling session, then 14 weekly group meetings, then 6 biweekly group meetings, then monthly group meetings. After 18 months, alternative options were offered, including individual counseling and special group sessions focused on selected weight loss topics. Focus included self-directed behavior change, nutrition and physical activity education, and social support for making and maintaining behavior changes. Behavior change techniques included self-monitoring, setting explicit short-term goals, developing action plans to achieve those objectives, and alternative strategies for situations triggering problem eating. Dietary intervention focused on reduced calorie intake by less consumption of fat, sugar, and alcohol, with a minimum daily calorie intake of 1500 kcal for men and 1200 kcal for women, and moderate weight loss goals of < 0.9 kg/wk. Physical activity goal was for gradually increased activity to moderate-intensity activity (40%-55% of heart rate reserve) 30 to 45 mins/day, 4-5 days/wk. Primary exercise was brisk walking. | |
| Knowler et al, 200281 | Standard lifestyle + placebo | Not noted | Not noted | Written information and an annual 20 to 30 minute individual session emphasizing importance of healthy lifestyles. Advice included encouragement to follow the USDA Food Guide Pyramid and equivalent of National Cholesterol Education Program Step I diet, reduce weight and increase physical activity. |
| Standard lifestyle + metformin | Not noted | Not noted | Same as for placebo, but with metformin titrated up to 875 mg twice a day. | |
| Intensive lifestyle | Not noted | Case managers | 16 session curriculum covering diet, exercise, and behavior modification taught by case managers on a 1:1 basis in the first 24 wks. Flexible, culturally sensitive, and individualized. Subsequent individual (typically monthly) and group sessions with case managers to reinforce behavioral change. | |
| Kuller et al, 200166 | Assessment only | Large research clinic | Psychologists (PhD level) | Clinical assessment, with baseline health education pamphlet on reducing cardiovascular risk factors, and advice to quit smoking. |
| Lifestyle intervention | Large research clinic | Psychologists (PhD level), nutritionists, exercise physiologists | Cognitive-behavioral program aimed at preventing rises in LDL cholesterol and weight gain and increasing leisure-time activity. Intensive group program in the first 6 mos, then follow-up individual and group sessions from months 6-54. Weight loss goal was 5-15 lbs, depending on baseline weight. Participants were asked to lower dietary fat intake and daily caloric intake. Lifestyle approach to increasing physical activity to expenditure 1000-1500 kcal/wk. | |
| Tuomilehto et al, 200167 | Control | Not noted | Not noted | General oral and written information about diet and exercise at baseline and at subsequent annual visits. 3-day food diary at baseline and at each annual visit. |
| Intervention | Not noted | Nutritionist | Detailed advice about how to achieve weight loss, diet, and exercise goals. Participants met with nutritionist 7 times over 1st year, then every 3 months. Dietary advice was tailored to each participant based on quarterly food diaries and included behavioral modification tips. Participants received individual guidance on increasing physical activity level. Endurance exercise (walking, jogging, swimming, aerobic ball games, or skiing) was recommended as a way of increasing aerobic capacity. Supervised, progressive, individualized circuit-type resistance training also offered for improving functional capacity and strength. | |
| Fogelholm et al, 200076 | Control (40 wk follow-up after 12 week weight reduction program) | Not noted | Nutritionist (weight loss phase) | 12-wk weight reduction program (wk 1: low energy diet based on meal exchange; wks 2-9 VLCD; weeks 10-12: low energy diets), with weekly small groups (5-12 participants) receiving instruction on diet, weight maintenance, relapse prevention. No increase in habitual exercise in the 40-wk follow-up. |
| Walking program (4.2 MJ/wk target expenditure) following 12 week weight reduction program | Not noted | Nutritionist (weight loss phase) exercise instructor (maintenance phase) | 12-wk weight reduction program as above. In maintenance program, each participant had a weekly walking time prescribed and walked with a heart rate monitor. One weekly walking session was supervised. All persons participated in weekly meetings in small groups throughout the maintenance program, conducted by an exercise instructor. Educational material was distributed monthly. Weekly homework included monitoring of high-risk situations for overeating. Problems in diet and prevention of relapse were discussed in the meetings. | |
| Walking program (8.4 MJ/week target expenditure) following 12-wk weight reduction program | Not noted | Nutritionist (weight loss phase), exercise instructor (maintenance phase) | 12-wk weight reduction program, then 40-wk walking weight maintenance program as described in the 4.2 MJ program above; only difference was increased targeted energy expenditure. | |
| Jakicic et al, 199972 | Short-bout exercise | Not noted | Nutritionists, exercise physiologists, and behavioral therapists | Behavioral weight loss program: group treatment meetings of diminishing frequency (weekly in mos 1-6, biweekly in mos 7-12, monthly in wks 13-18). Meetings focused on behavioral strategies for modifying eating and exercise behaviors. Participants were instructed to reduce daily energy and fat intake. Caloric goal based on baseline weight, with goal of 0.45-0.9 kg loss per wk. Fat intake goal was 20% of total intake. Food diaries reviewed weekly, with feedback from interventionists. Exercise: same volume of exercise, all home based, in all 3 groups. Participants instructed to exercise 5 days/wk: initially 20 mins/day (wks 1-4), increasing to 40 mins/day by wk 9. Exercise was divided into multiple 10-min bouts performed at convenient times in the day. |
| Long-bout exercise | Not noted | Nutritionists, exercise physiologists, and behavioral therapists | Behavioral weight loss program as in the short-bout exercise arm. Exercise: daily total exercise amounts as described in the short-bout exercise arm. Exercise was to be performed in 1 long bout. | |
| Short-bout exercise with equipment | Not noted | Nutritionists, exercise physiologists, and behavioral therapists | Behavioral weight loss program as in the short-bout exercise arm. Exercise: daily total exercise amounts as described in the short-bout exercise arm. Participants were provided with motorized home treadmills. | |
| Jones et al, 199969 | Control | Not noted | Study nurse | Participants were told that they should lose weight, but received no formal diet counseling or group support. |
| Weight loss | Not noted | Registered dietitian | Patients individually counseled within 10 days of randomization, and 2-4 wks later. Content focused on food selection and preparation, and weight reduction goals were established. No exercise advice. They met in groups twice monthly for 3 mos, then every 3-6 mos. | |
| Sbrocco et al, 199974 | Behavioral choice treatment | Not noted | Clinical psychologist or clinical social worker (also a psychology graduate student) with extensive experience in the behavior treatment of obesity. Two inexperienced graduate students (psychology) were co-leaders | 13 weekly 1.5 hr group sessions with 5-7 members per group. Participants received 2-wk meal plans and recipe booklets for a low fat (25%) diet: 1800 kcal/day. Diaries reviewed, with immediate feedback each session—including graphs of daily fat and calorie intake and a list of highest-fat foods and some alternatives. Participants encouraged to eat at a constant calorie level. Self-monitoring phased out before acute treatment ended. Participants were encouraged to complete a walking program 30 mins/day, 3 days/wk in a single bout. No formal exercise groups, but daily exercise logs. Stated purpose: to stop dieting and to view eating as a choice; to expect slower weight loss than they had experienced in the past, but more permanent change. Health behavior including food choice, avoiding exercise, eating behaviors discussed as choices designed to achieve certain outcomes. Individuals taught to identify their choices and the outcomes controlling these choices and to focus on learning to eat in a manner consistent with a reasonable eventual end-goal weight, rather than focusing on how quickly weight can be lost. |
| Traditional behavioral treatment | Not noted | Clinical psychologist or clinical social worker (also a psychology graduate student) with extensive experience in the behavior treatment of obesity. Two inexperienced graduate students (psychology) were co-leaders | Weekly group sessions, meal plans, recipes, food diaries, and exercise as above, but with 1200 kcal/day diet. Stated purpose: to promote substantial weight loss and to help develop habits and strategies to maintain this loss. Standard behavioral weight management techniques (e.g., self-monitoring, stimulus control, and behavioral substitution) were taught. Participants were encouraged to avoid eating and purchasing high-calorie foods, to lose weight so they could then maintain these changes; they were taught to understand their reasons for eating and to engage in problem solving to determine other methods to respond to stress. | |
| Ashley et al, 200182 | Dietitian-led lifestyle intervention | Not noted | Registered dietitian | 26 1-hour sessions over 1 year. Participants received instruction manuals that included lessons based on an established weight control program (LEARN). Diet included a LCD (1200 kcal/day, with < 30% of calories from fat), using standard recommendations for food groups and portion sizes. Activity instruction included walking up to 10,000 steps/day, measured by a supplied pedometer. Self-monitoring of food intake and energy expenditure in diaries. Specific to this group, participants attended small (8-10 people) classes led by a registered dietitian. Classes were weekly for 3 mos, then biweekly for 3 mos, then monthly for 4 mos. Diet was made up of conventional food items. |
| Dietitian-led lifestyle intervention with meal replacements | Not noted | Registered dietitian | As in the traditional group above, instruction manuals for dieting, 1200-kcal diet, and exercise instructions with pedometer use and self-monitoring. Sessions with registered dietitian as above. However, 2 of the 3 main meals were replaced with meal-replacement shakes or bars (reduced to 1 main meal if goal reached and maintained). | |
| Primary care office intervention with meal replacements | Physician office | Primary care physician (2/3 of visits) or registered nurse (1/3 of visits) | 26 biweekly 10-15 min individual sessions over 1 yr, with a focus of helping patients lose weight (although other related medical problems were also discussed). Diet prescription with meal replacements as in the "dietitian-led with meal replacement" plan above. During each visit, diet, behavior modification, and physical activity habits were reviewed, and questions answered about the diet instructions. | |
| Wadden et al, 200168 | Sibutramine alone | Not noted | Physician | Baseline meeting with a physician who described medication use and the importance of lifestyle modification. A balanced diet (1200-1500 kcal/day) was prescribed. Gradually increased exercise (typically walking) to 4-5 sessions/wk, each of 30-40 mins duration. Literature supporting these instructions was disseminated. Over the trial, patients had 10 brief (5 to 10 minute) follow-up visits with the physician (weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 52). No lifestyle counseling or instruction for self-monitoring of lifestyle change. |
| Sibutramine + lifestyle | Not noted | Physician (outcomes monitoring) doctoral-level psychologists (counseling) | Physician visits on same schedule as sibutramine alone group. Additionally, in the first 20 weeks, they attended weekly psychologist-led group lifestyle modification sessions. They were prescribed the same diet and exercise goals as the drug-only group but were given behavioral strategies for achieving them and were asked to self-monitor food intake and physical activity for at least 16 wks. Behavioral topics discussed at weekly sessions included stimulus control, slowed rate of eating, social support, and cognitive restructuring. During wks 24-52, sessions focused on skills for maintenance of weight loss. | |
| Sibutramine + lifestyle + diet | Not noted | Physician (outcomes monitoring) doctoral-level psychologists (counseling) | Identical intervention to the sibutramine plus lifestyle group, with the addition of the 1st 16 wks prescription of a 1000 kcal/day portion-controlled diet (4 servings/day of a liquid nutritional supplement with an evening balanced meal). After wk 16, gradually decreased consumption of liquid supplement, with 1200-1500 kcal diet of conventional food diet by wk 20 (similar to the patients in the other 2 arms). | |
| Wing and Anglin, 199678 | Behavior therapy with LCD | Not noted | Multidisciplinary team (all white) | 1 yr of weekly sessions, including review of self-monitoring records, weighing, and a lecture/discussion on nutrition, behavioral techniques, or exercise. Topics included stimulus control, goal setting, and self-monitoring of diet and exercise. Participants encouraged to gradually increase activity until walking 2 miles/day, 5 days/wk. Participants followed a LCD (1000-1200 kcal/day), with < 30% calories from fat. |
| Behavior therapy with intermittent VLCD | Not noted | Multidisciplinary team (all white) | Counseling and behavioral therapy as above for diet and exercise. Intermittent VLCD in weeks 1-12 and 24-36. During VLCD intervals, goal consumption of approximately 500 kcal/day, either as liquid formula or lean meat, fish, or fowl. After each VLCD, other foods gradually reintroduced until consumption of 1000-1200 kcal/day was reached. | |
aInformation was primarily obtained from the published sources listed. In selected cases (Tuomilehto et al,67 Kuller et al66), additional information was obtained from study staff. LCD = low calorie diet; LDL = low-density lipoprotein; VLCD = very low calorie diet; USDA = U.S. Department of Agriculture. | ||||