Table 2. Randomized Controlled Trials of Counseling and Behavioral Interventions

High Intensity

Study, Year	Goal and Components	Sample Size (N), Race, Sex, and Age^a	Body Mass Index (kg/m²)^b	Study Duration	Groups^c	Weight Change	Between-Group Differences^d	P Value	Patients Lost to Followup	Study Quality
Stevens et al, 2001⁷⁰	L + M D, E, B G + I	N: 1191 White: 79% Black: 18% F: 34% Age: 43 yrs	31	18 mo	Weight loss	-2 kg	-2.7 kg	< 0.001	8% at 36 mo	Good
				18 mo	Control	0.7 kg	-2.7 kg	< 0.001
				36 mo	Weight loss	-0.2 kg	-2.0 kg	< 0.001
				36 mo	Control	1.8 kg	-2.0 kg	< 0.001
Kuller et al, 2001⁶⁶	L + M D, E, B G + I	N: 535 White: 92% F: 100% Age: 47 yrs	25	54 mo	Lifestyle change	-0.09 kg	-2.5 kg	< 0.001	5%	Good
Kuller et al, 2001⁶⁶	L + M D, E, B G + I	N: 535 White: 92% F: 100% Age: 47 yrs	25	54 mo	Assessment only	2.4 kg	-2.5 kg	< 0.001	5%	Good
Tuomilehto et al, 2001⁶⁷	L D, E, B G	N: 522 Race: NR F: 67% Age: 55 yrs	31	1 yr	Intervention	-4.2 kg	-3.4 kg	< 0.001	8%	Good
				1 yr	Control	-0.8 kg	-3.4 kg	< 0.001
				2 yr	Intervention	-3.5 kg	-2.7 kg	< 0.001
				2 yr	Control	-0.8 kg	-2.7 kg	< 0.001
				1 yr		Freq. 5% loss:
					Intervention	NR	30%	0.001
					Control	NR	30%	0.001
Fogelholm et al, 2000⁷⁶	L + M D, E, B G	N: 82 Race: NR F: 100% Range: 30-45 yrs	34	1 yr	1st PA program	-0.7 kg	-2.7 kg	0.06	10%	Fair
					2nd PA program	-0.6 kg	-2.6 kg
					Control	2.0 kg
				2 yr	1st PA program	5.9 kg	-3.8 kg	0.07
					2nd PA program	9.2 kg	-0.5 kg
					Control	9.7 kg
Knowler et al, 2002⁸¹	L + M D, E, B G + I	N: 3234 White: 55% Black: 20% Hispanic: 16% American Indian: 5% Asian: 4% F: 68% Age: 51 yrs	34	2.8 yr	Metformin	-2.1 kg	-2.0 kg	< 0.001	7.5%	Good
					Lifestyle	-5.6 kg	-5.5 kg
					Placebo	-0.1 kg
						Freq. > 7% loss:
					Metformin	NR
					Lifestyle	38%
					Placebo	NR
Jakicic et al, 1999⁷²	L D, E, B G	N: 148 Race: NR F: 100% Range: 25-45 yrs	Weight 20%-75% higher than ideal body wt	18 mo	Long-bout PA	-5.8 kg	-2.1 kg	< 0.05 NS all other pairs	22% (13% – 29% per group)	Fair
					Short-bout PA + EQ	-7.4 kg	-3.7
					Short-bout PA	-3.7 kg	(referent)
Jones et al, 1999⁶⁹	L D, B G + I	N: 102 White: 60% Black: 40% F: 52% Intervention: 57 yrs Control: 59 yrs	34	6 mo	Weight loss	-3.2 kg	-1.4 kg	0.05	9%	Fair
				6 mo	Control	-1.8 kg	-1.4 kg	0.05
				12, 18, 24, 30 mo		NR	NR	NS
Sbrocco et al, 1999⁷⁴	L D, E, B G	N: 24 Race: NR F: 100% Age: 40-43 yrs (varied by group)	33	12 mo	Behavioral choice	-10.1 kg	-5.76 kg	0.01	17%	Fair
Sbrocco et al, 1999⁷⁴	L D, E, B G	N: 24 Race: NR F: 100% Age: 40-43 yrs (varied by group)	33	12 mo	Traditional behavioral treatment	-4.3 kg	-5.76 kg	0.01	17%	Fair
Wadden et al, 2001⁶⁵	L D, E, B G	N: 53 Race: NR F: 100% Age Drug: 46 Drug, L: 41 Drug, D, L: 40	36-39	1 yr	Sibutramine + diet + lifestyle	-16.6 kg	-12.8 kg	< 0.05	32%	Fair
					Sibutramine + lifestyle	-11.1 kg	-7.3 kg	< 0.05
					Sibutramine	-3.8 kg 59% of drug + diet + lifestyle participants had lost > 15% of weight at 1 yr	(referent)
Ashley et al, 2001⁸²	L D, E, B G + I	N: 113 Race: NR F: 100% Age: 41-42 yrs (varied by group)	25-35	1 yr	Primary care visit, meal replacement	-3.5 kg	-0.1 kg	NS	32%-38%	Fair
					Nutritionist, meal replacement	-7.7 kg	-3.7 kg	< 0.05
					Nutritionist alone	-3.4 kg	(referent)
Wing and Anglin, 1996⁷⁸	L D, E, B G	N: 93 Black: 17% White: 80% Other: 2% Female Black: 75% White: 66% Age Black: 49 yrs White: 52 yrs	Black: 37 White: 38	1 yr	Behavioral therapy, with very-low-calorie diet	Black: -13 kg White: -17 kg	Black: -2 kg White: -4 kg	NR	19%	Fair
Wing and Anglin, 1996⁷⁸	L D, E, B G		Black: 37 White: 38	1 yr	Behavioral therapy with low-calorie diet	Black: -11 kg White: -13 kg Weight loss is approximate, from graphic data	(referent) Weight loss is approximate, from graphic data
Leermakers et al, 1999⁷³	M D, E, B G	N: 67 White: 94% F: 80% Age: 50.8 yrs	31	18 mo	Weight focused maintenance program	3.1 kg	-2.1 kg	< 0.05	15% at 6 mo;	Fair
					PA-focused maintenance program	5.2 kg	-2.1 kg	< 0.01	28% at 18 mo
					Weight-focused program	90% original weight loss maintained	-36%
					PA-focused program	54% original weight loss maintained	-36%

Moderate Intensity

Study, Year	Goal and Components	Sample Size (N), Race, Sex, and Age^a	Body Mass Index(kg/m²)^b	Study Duration	Groups^c	Weight Change	Between-Group Differences^d	P Value	Patients Lost to Followup	Study Quality
Lindholm et al, 1995⁷⁹	L D, E G	N: 681 Race: NR F: 15% Range: 30-59 yrs	Intervention Men: 27 Women: 30 Control Men: 27 Women: 29	18 mo	6 sessions of health care advice Usual care	NR NR	-0.25 kg	NS	6%	Good
Swinburn et al, 1999⁷¹	L D, B G	N: 176 Intervention European: 69% Maori: 12% Pacific Islander: 14% Other: 4% Control European: 75% Maori: 7% Pacific Islander: 4% Other: 3% F Intervention: 21% F Control: 35% Intervention 53.2 yrs Control 52.3 yrs	Intervention 84 kg	12 mo	Reduced fat diet	-3.1 kg	-3.5 kg	< 0.001	38%	Fair
Swinburn et al, 1999⁷¹	L D, B G		Control 85 kg	12 mo	Usual diet	0.4 kg	-3.5 kg	< 0.001	38%	Fair

Low Intensity

Study, Year	Goal and Components	Sample Size (N), Race, Sex, and Age^a	Body Mass Index(kg/m²)^b	Study Duration	Groups^c	Weight Change	Between-Group Differences^d	P Value	Patients Lost to Followup	Study Quality
Jeffery and French, 1997⁷⁷	L D, E G	N: 822 Each group White: 76%-94% F: 81% Age: 31-37 yrs (varied by group)	Men: 28 Women: 26-28	12 mo	Lifestyle edu Edu + lottery Control	Men 0.72 lb 0.21 lb 1.94 lb	-1.22 lb -1.73 lb	NS NS	14%	Good
					Lifestyle edu Edu + lottery Control	Women (High SES): 1.03 lb 0.51 lb 1.38 lb	-0.35 lb -0.87 lb	NS NS
					Lifestyle edu Edu + lottery Control	Women (Low SES): 2.11 lb 3.23 lb 1.30 lb	+0.81 lb +1.93 lb	NS NS
Bemelmans et al, 2000⁸³	L D G	N: 266 Race: NR F Intervention: 51% F Control: 63% Female: 51% Age: 54-55 yrs (differed by group)	30	52 wk	Dietary interventions with group meetings and mailings	Men: 0.5 kg/m² Women: 0.3 kg/m²	Men: 0.1kg/m² Women: 0 kg/m²	NS NS	8%	Fair (but non-randomized)
Bemelmans et al, 2000⁸³	L D G		30	52 wk	Leaflet of Dutch nutritional guidelines	Men: 0.4 kg/m² Women: 0.3 kg/m²	Men: 0.1kg/m² Women: 0 kg/m²	NS NS	8%	Fair (but non-randomized)
Rothacker et al, 2001⁶⁸	M D I	N: 75 Race: NR F: 100% Range: 18-55 yrs	25	1 yr	Pre-measured low-calorie liquid supplements	-6.3 kg	-5 kg	< 0.001	17%	Fair
Rothacker et al, 2001⁶⁸	M D I	N: 75 Race: NR F: 100% Range: 18-55 yrs	25	1 yr	Low-energy, low-fat foods	-1.3 kg	-5 kg	< 0.001	17%	Fair
OXCHECK Study Group 1995⁸⁰	L D I	N: 2205 Race: NR F: 47% Range: 35-64 yrs	NR	NR	Health checks	NR	At followup, those with health checks were 0.38 kg/m² less than controls	< 0.05	25%	Fair
OXCHECK Study Group 1995⁸⁰	L D I	N: 2205 Race: NR F: 47% Range: 35-64 yrs	NR	NR	Standard care	NR		< 0.05	25%	Fair
^a Mean values unless otherwise noted. ^b Baseline mean or range unless otherwise noted. ^c See Appendix Table 3 for details. ^d Compared with control unless otherwise noted. B = behavioral therapy; D = diet; E = exercise; EQ = exercise equipment; G = group-based; I = individual-based; L = weight loss; M = maintenance of weight loss; NR = not reported; NS = not significant; OXCHECK = Oxford and Collaborators ChecK; PA = physical activity; SES = socioeconomic status.

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