Table 2.

Trial outcomes for 38 randomized controlled trials of behavioral interventions

Trial	Behavior outcome	Effect size (95 % CT)	Group difference in original units	Primary physiological outcome	Effect size (95 % CI)	Group difference in original Units	Morbidity	Mortality
ACT [22]a	Met activity recommendationsN, S	0.4 (0.03, 0.77)	25.7 versus 14.3 %	VO2 (ml/min)B, O	0.32 (0.08, 0.57)	80.7 ml/min	NR	NR
Be Fit, Be Well [32]	Medication adherence scaleB, S	0.38 (0.13, 0.63)	0.85 units different on medication adherence scale	WeightB, O	0.25 (0.01, 0.50)	1.05 kg	NR	NR
BPTEACH [33]	NR	NR	NR	Systolic blood pressureN, O	0.22 (0.18, 0.61)	9.44 mmHg	NR	NR
DEER [34]	Caloric intakeB, S	0.48 (0.07, 0.91)	172 kcal/day	LDL-CB, O	0.62 (0.19, 1.05)	12 mg/dl	NR	NR
DISH [35]b	NR	NR		WeightB, O	0.83 (0.48, 1.2)	3.5 kg	Normotensive without drugs—benefit	NR
DPP [15, 36]	Energy intakeB, S	0.23 (0.15, 0.32)	201 kcal/day	WeightB, O	0.81 (0.73, 0.90)	5.4 kg	Diagnosis of diabetes—benefit	NR
ENRICHD [37]	DepressionB, S	0.33 (0.25, 0.41)	2.8 points on Beck Depression	NR	NR	NR	Fatal or non-fatal myocardial infarction—null	Yes—null
HARP [38]	Pill countN, O	0.04 (−0.16, 0.25)	2 % more adhered	NR	NR	NR	NR	NR
HART [39]	SodiumN, S	0.31 (0.14, 0.49)	10 % more met goal	Systolic blood pressureN, O	0.11 (−0.01, 0.24)	2.6 mmHg	Heart failure or hospitalization—null	Yes—null
HCP [40]	SodiumB, O	1.12 (0.72, 1.5)	1,839 mg/day	Diastolic blood pressureB, O	0.22 (0.14, 0.58)	1.5 mmHg	Normotensive without drugs—benefit	NP
Health Literacy [41, 42]	Self-care behaviorB, S	0.56 (0.38, 0.73)	1.4 points on self-care scale	NR	NR	NR	Hospitalizations—null	Yes—null
Help PD [43]c	NR	NR	NR	Glucose mg/dlB, O	0.44 (0.22, 0.67)	4.35 mg/dl	Diagnosis of Diabetes—null	NR
HF-ACTION [44]d	6 min walkB, O	0.32 (0.2, 0.41)	14 m	VO2 (ml/kg/min)B, O	0.34 (0.25, 0.42)	0.4 mL/kg/min	CV event or hospitalization—null	Yes—null
HOME_BP [45]	NR	NR	NR	Blood pressure controlN, O	0.09 (−0.15, 0.33)	25 % of tx had bp control versus 22 % con	NR	NR
HOPP [46]	SmokingB, S	0.22 (0.03, 0.41)	9 % remained abstinent	NR	NR	NR	NR	NR
HPT [47]	SodiumB, O	0.32 (0.11, 0.53)	5.5 mmol	Blood pressureN, O	0.21 (0.0, 0.42)	1.7 mmHg	Hypertension—benefit	NP
Htn Prev [48]	SodiumB, O	0.63 (0.33, 0.99)	700 mg/day	Blood pressureB, O	0.31 (0.03, 0.60)	2 mmHg	Hypertension—benefit	NR
ICAN [49]	NR	NR	NR	WeightB, O	0.42 (0.09, 0.75)	3.0 kg	NR	NR
IN CONTROL [50]	Completed FU appointmentB, O	0.42 (0.16, 0.66)	65.1 versus 46.7 %	NR	NR	NR	NR	NR
iReach [23]e	Diet (kcal)N, O	0.03 (−0.18, 0.25)	18 kcal	Weight (kg)B, O	0.36 (0.14, 0.58)	2.1 kg	NR	NR
Look Ahead [2, 3, 51, 52]f	Physical activity (kcal/week) B, S	0.34 (0.29, 0.40)	768.9 kcal/week	Change in METS from sub-max treadmillB, O	0.59 (0.53, 0.64)	15.1 METS	Composite of cardiovascular events—null	Yes—null
Mediterranean Lifestyle [53–55]	Adherence to Mediterranean diet scaleB, S	0.77 (0.52, 1.02)	0.86 point increase with possibly scale range 0–7	Weight (kg at 6 months)B, O	0.35 (0.11, 0.59)	1.77 kg	NR	NR
MRFIT [56–59]g	Smoking cessationB, O	0.66 (0.59, 0.72)	31 versus 12 % quit rate	Blood pressure (diastolic)B, O	0.41 (0.38, 0.45)	3.8 mmHg	Definite, fatal AMI—null	Yes—null
Optimal Exercise Regimens [60]	NR	NR	NR	VO2 max (mL/kg/min)B, O	0.58 (0.14, 1.03)	2.0 ml/kg/min	NR	NR
PADRF [31]	Increased dose or use of medicationB, O	0.94 (0.61, 1.27)	53.8 versus 17.5 %	LDL-CB, O	0.36 (0.08, 0.63)	10.5 mg/dl	NR	NP
PAD Treadmill [61]	6 min walk (m)B, O	0.69 (0.29, 1.08)	36.2 m	Brachial artery flow (mm)B, O	0.22 (−0.16, 0.61)	0.06 mm	NR	NR
POWER [62]	NR	NR	NR	WeightB, O	0.89 (0.63, 1.16)	4.5 kg	Hospitalizations—null	NP
POWER-UP [63]	NR	NR	NR	WeightN, O	0.16 (0.08, 0.40)	1.1 kg	NR	NP
PREMIER [64]	Fruit and vegetable intakeB, S	0.78 (0.59, 0.97)	2.5 servings/day	Blood pressure (systolic)B, O	0.47 (0.30, 0.64)	4.3 mmHg	NP	NR
SCRIP [65]	% Kcal fatB, S	1.09 (0.82, 1.36)	7.8 % kcal fat	Minimal diameter changeB, O	0.30 (0.05, 0.55)	0.069 mm	Hospitalizations—benefit	Yes—null
SWCP [66]	Energy intakeB, S	0.92 (0.45, 1.38)	2,213 kJ/day	CHD risk (using Framingham equations)B, O	1.11 (0.64, 1.58)	−22.4 events/1,000 persons	NR	NR
TCYB [67],h	NR	NR	NR	Blood pressure controlledB, O	NR	11 % more of tx group had controlled blood pressure	NR	NP
TELE-HF [68]	NR	NR	NR	NR	NR	NR	Readmission—null	Yes–null
TOHP [69],i	NR	NR	NR	Blood pressure (systolic)B, O	NR	−2.7 mmHg	Onset of hypertension—benefit	NR
TOURS [70]	Self-monitoring recordsB, O	0.32 (0.01, 0.63)	29 more days of self-monitoring	Weight regainB, O	0.43 (0.12, 0.74)	2.5 kg	NR	NR
TLC [71]	NR	NR	Attendance	VO2 max (mL/kg/min)N, O	0.38 (−0.2, 0.77)	0.8 ml/kg/min	NR	NR
WHI-DM [72]	% fat intakeB, S	1.51 (1.49, 1.53)	10.7%	Blood pressure (diastolic)B, O	0.03 (0.01, 0.05)	−0.31 mmHG	Fatal and non-fatal CHD, CVD, stroke—null	Yes—null
WLM [73]j	% KcalN, S	NR	NR	WeightB, O	0.27 (0.12, 0.42)	1.5 kg	NR	NR

Primary outcomes and effect sizes for trials included in review. See Online Appendix Table 3 for further details. Data in cells are the primary outcome, calculated absolute effect sizes, and reported change in original trial units for the behavioral, physiological, and weight outcomes. Superscripted letters represent whether measure was objective or self-reported and whether outcome was a significant benefit or null. For morbidity outcomes, we include the specific outcome measure and whether null or significant benefit. If the trial was powered to analyze all-cause mortality, we included whether there was a significant benefit or not. 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. A total of 38 trials are included. Each type of outcome (behavior, weight, physiology, morbidity, and mortality outcomes) should total to 38. Each trial was categorized as reporting a significant benefit or null finding or not reported/not powered for each type of outcome. Behavior, weight, and physiological outcomes were reported at the end of the intensive intervention. Morbidity and mortality outcomes were reported at the longest follow-up period available

^aACT—behavior effect size calculated from proportions–percent of participants meeting moderate or vigorous physical activity recommendations post–intervention

^bDISH—two intervention arms—weight control and sodium control. Outcomes for weight control arm are reported in the 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

^cHelp-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

^dHF action—the main outcome paper reported median and IQR for the behavior (distance walked) and physiological variable (peak oxygen consumption). We calculated effect sizes based on a normal distribution assumption

^eiReach—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

^fLook Ahead—different FU—behavior outcome VO₂ and weight reported at 12 months; Cardiovascular events and mortality reported at final follow-up (max 13.5 years, median 9.6 years)

^gMRFIT—behavior and physiological outcomes reported at 12 months; AMIs reported at 7 years; and mortality reported at original follow-up (max 6 years)

^hTCYB—insufficient data presented to calculate blood pressure effect sizes

ⁱTOHP—insufficient data presented to calculate blood pressure effect sizes

^jWLM—insufficient data presented to calculate change in percent kcal effect sizes

NR not reported, N null, B significant benefit, H harm, O objective, S self-reported, ACT [22] activity counseling trial, Be Fit, BeWell [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] hypertension 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 tele-monitoring 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