Table 1.
Selected trial details of the 38 included behavioral interventions
| Trial | Intervention | Comparator | Intervention length (intensive/full) |
Participant description |
N size intervention |
N size comparator |
|---|---|---|---|---|---|---|
| ACT [22] | Exercise | Brief provider advice | 24 months/24 months | Inactive adults (women) | 130 | 133 |
| Be Fit, Be Well [32] | Multi-factor (diet, exercise) | Usual care and education materials | 12 months/24 months | Obese patients receiving hypertension treatment | 148 | 166 |
| BPTEACH [33] | Patient education to ask clinicians | Usual care | 6 months | African American hypertensives | 43 | 57 |
| DEER [34]b | Multi-factor (diet, exercise) | Assessment only | 3 months/12 months | Postmenopausal adult women | 43 | 45 |
| DISH [35]c | Diet for weight control | No medication control | 56 weeks | Participants in previous heart disease trial | 87 | 89 |
| DPP [15, 36]a | Multi-factor (diet, exercise) | Placebo | 24 weeks/2.8 years | Pre-diabetic | 1,079 | 1,082 |
| ENRICHD [37] | Cognitive behavioral therapy | Education materials | 6 months, 9 months | Patients with MI in past 28 days | 1,238 | 1,343 |
| HARP [38] | Med adherence | Cancer control | 6 months | Hypertensive adults | 221 | 213 |
| HART [39] | Self-management counseling | Heart failure education | 12 months | Patients with mild to moderate heart failure | 451 | 451 |
| HCP [40] | Nutrition | Discontinued drug use | 4 years | Participants in previous heart disease trial | 97 | 44 |
| Health Literacy [41, 42]a | Health literacy | Single session health literacy | 1 months, 12 months | Patients with heart failure | 303 | 302 |
| Help PD [43]d | Multi-factor (diet, exercise) | Usual care + registered dietician advice | 6 months, 24 months | Pre-diabetic | 151 | 150 |
| HF-ACTION [44]a | Exercise | Education materials | 3 months, 12 months | Patients with heart failure | 1,159 | 1,172 |
| HOME_BP [45] | Home blood pressure monitor | Home blood pressure monitor and log | 3 months | High-risk African American patients | 221 | 217 |
| HOPP [46] | Smoking cessation | Education materials | 6 months, 7 months | Pregnant smokers | 306 | 297 |
| HPT [47] | Diet (sodium restriction) | Assessment only | 10 weeks, 3 years | Adults with mid-range blood pressure | 196 | 196 |
| Htn Prev [48] | Multi-factor (diet, exercise, sodium) | Usual care | 5 years | Adults with mild hypertension | 102 | 99 |
| ICAN [49] | Multi-factor (diet, exercise) | Usual care | 12 months | Obese, type 2 diabetics | 73 | 71 |
| IN CONTROL [50] | Blood pressure monitor | Usual care | 3 months | Adults with elevated blood pressure | 209 | 212 |
| iReach [23]e | Multi-factor (diet, exercise) | In person | 6 months | Overweight adults | 158 | 161 |
| Look Ahead [2, 3, 51, 52]a | Multi-factor (diet, exercise) | Usual care and diabetes education | 6 months, 4 years | Overweight/obese, type 2 diabetics | 2,570 | 2,575 |
| Mediterranean Lifestyle [53–55] | Multi-factor (diet, exercise) | Usual care | 6 months | Post-menopausal women, type 2 diabetics | 163 | 116 |
| MRFIT [56–59] | Multi-factor (smoking, diet) | Usual care | 4 months, 6 years | Men at risk of CHD death but no clinical evidence | 6,428 | 6,438 |
| Optimal Exercise Regimens [60] | Exercise | Assessment only | 12 months | Sedentary adults (men reported here) | 40 | 41 |
| PAD_RF [31] | Patient education to ask clinicians | Attention control | 12 months/12 months | Patients with PAD | 97 | 111 |
| PAD Treadmill [61] | Exercise | Assessment only | 6 months | Patients with peripheral artery disease | 51 | 53 |
| POWER [62] | Multi-factor (diet, exercise) remote counseling | Usual care | 6 months, 24 months | Obese adults | 139 | 138 |
| POWER-UP [63] | Multi-factor (diet, exercise) Brief lifestyle counseling | Usual care and quarterly counseling | 12 months, 24 months | Obese adults | 131 | 130 |
| PREMIER [64] | Multi-factor (diet, exercise, sodium) Established + DASH diet | Education materials and 1-time counseling | 6 months, 18 months | Adults with untreated pre- or stage 1 hypertension | 269 | 273 |
| SCRIP [65] | Multi-factor (diet, exercise, sodium, smoking) | Usual care | 4 years | Adults with atherosclerosis | 145 | 155 |
| SWCP [66]f | Multi-factor (diet, exercise) | Assessment only | 3 months, 12 months | Moderately overweight (men | 39 | 40 |
| TCYB [67] | Blood pressure monitor | Usual care | 24 months | Hypertensive adults | 159 | 159 |
| TELE-HF [68] | Telemonitoring | Education materials | 180 days | Recently hospitalized for heart failure | 826 | 827 |
| TOHP [69] | Multi-factor (diet, exercise) | Usual care | 14 months, 3–4 years | Recent weight loss participants | 595 | 596 |
| TOURS [70] | Multi-factor (diet, exercise) | Education materials | 12 months | Obese women in rural areas who recently completed lifestyle intervention | 83 | 79 |
| Training level comparison [71] | High-intensity exercise | Low-intensity exercise | 12 months | Male adults with coronary heart disease | 103 | 82 |
| WHI-DM [72]g | Nutrition personal contact | Education materials | 1 year, 6.1 years | Overweight or obese with hypertension, dyslipidemia | 19,541 | 29,294 |
| WLM [73] | Multi-factor (diet, exercise) | Self-directed maintenance | 30 months | Postmenopausal women | 341 | 341 |
See online Appendix Table 2 for further details. Data in cells are study acronym (see footnote at end), intervention and comparator detail treatment and control arms. Intervention length is described as the intensive period (if any) and the full intervention period. Participant description and sample sizes for both arms. Trial titles from registry or publications for each acronym are provided. Some trials did not provide a short title or acronym; therefore, study authors created a condensed title
ACT [22] activity counseling trial, Be Fit, Be Well [32] evaluating a blood pressure reduction and weight loss program in a low-income, ethnically diverse population, BPTEACH [33] Baltimore partnership to educate and achieve control of hypertension, DEER [34] diet and exercise for elevated risk, DISH [35] dietary intervention study for hypertension, DPP [15, 36] diabetes prevention program, ENRICHD [37] enhancing recovery in coronary heart disease patients, HARP [38] hypertension and adherence in rural practice, HART [39] heart failure adherence and retention randomized behavioral trial, HCP [40] hypertension control program, Health Literacy [41, 42] health literacy and self-management in heart failure, Help PD [43] healthy living partnerships to prevent diabetes, HF-ACTION [44] heart failure: a controlled trial investigating outcomes of exercise training (HF-ACTION), HOME_BP [45] home-based blood pressure interventions for African Americans, HOPP [46] healthy options for pregnancy and parenting, HPT [47] hyper-tension prevention trial, Htn Prev [48] primary prevention of hypertension by nutritional-hygienic means, ICAN [49] improving control with activity and nutrition, IN CONTROL [50] hypertension reduction in inner city Seattle, iReach [23] Internet-assisted obesity treatment, Look Ahead [2, 3, 51, 52] action for health in diabetes, Mediterranean Lifestyle [53–55] effect of the Mediterranean lifestyle program on multiple risk behaviors and psychosocial outcomes, MRFIT [56–59] multiple risk factor intervention trial, Optimal Exercise Regimens [60] optimal exercise regimens for persons at increased risk, PAD_RF [31] reducing risk factors in peripheral arterial disease, PAD Treadmill [61] improving functioning in peripheral arterial disease, POWER [62] practice-based opportunities for weight reduction, POWER-UP [63] practice-based opportunities for weight reduction trial at the University of Pennsylvania, PREMIER [64] lifestyle intervention blood pressure control, SCRIP [65] Stanford coronary risk intervention project, SWCP [66] Stanford weight control program, TCYB [67] take control of your blood pressure study, TELE-HF [68] Yale heart failure telemonitoring study, TOHP [69] trials of hypertension prevention, phase II, TOURS [70] treatment of obesity in underserved rural settings, Training Level Comparison [71] training level comparison trial, WHI-DM [72] Women's Health Initiative randomized controlled dietary modification trial, WLM [73] weight loss maintenance randomized controlled trial
For trials with this superscript, we had to extract data from multiple papers
The Deer study had 12-month intervention with the first 3 months intensive but only reported 12-month data
DISH—two intervention arms—weight control and sodium control. Outcomes for weight control arm reported in table. For sodium control arm, behavioral outcome was urinary sodium output which was significantly improved in treatment versus controls and more of the intervention group remained normotensive but not statistically different than controls
Help-PD—intensive intervention was the first 6 months. Main outcome paper reports data every 6 months but conducted statistical analyses for the 18- and 24-month data. Data reported for weight and physiological outcome (glucose) was the adjusted means over 18- and 24-month follow-up
iReach—study authors compared an in-person to an Internet or Internet in-person hybrid study. Authors evaluated how well an Internet delivery would do compared with an in-person version. We coded the in-person arm as the treatment arm and the Internet delivery arm as the control
SWCP was a 12-month intervention with the first 3 months intensive; however, only 12-month data were available in the publication
WHI had an intensive intervention for 12 months and then quarterly contact through the remainder of the year. Behavioral outcomes are reported at 18 months. Physiological outcomes were not published at 12 or 18 months. The closest follow-up to the end of the intensive intervention was at 3 years