Table 5. Randomized Controlled Trials Addressing Overweight in Children and Adolescents

Study Reference N Randomized
Country
Age
% Male
% Non-white
Baseline Measure of Overweight  Intervention Characteristicsa
Components
Comprehensive?
Parent participation?
Group vs. Indiv.
Time period
# of Sessions
Session length
Total contact time (min)
Berkowitz, 200386  82 adolescents
USA
13-17
33%
45%
BMI 37.8 kg/m2 (3.8);
BMI z-score: 2.4 (0.2)
BM,D,E
yes
yes
G
6 mo (phase I)
19 (phase I)
NR
NR
Duffy, 199387 29 children
Australia
7-13
21%
NR, Australian
48.4% overweight BM,D,E
yes
yes
NR
8 wk
8
90 in
720 min
Ebbeling, 200388  16 adolescents
USA
13-21
31%
19%
BMI 34.9 kg/m2 (reduced glycemic group);
 37.1 kg/m2(reduced fat diet group)
BM,D
No
No
NR
12 mo
14
NR
NR
Epstein, 198589 41 families
USA
8-12
40%
NR
 48% overweight BM,D,E
yes
yes
NR
12 mo
18
NR
NR
Epstein, 198590  23 children
USA
8-12
0%
NR
48 % overweight  BM,D,E
yes
yes
NR
12 mo
NR
NR
NR
Epstein, 198591   24 children
USA
5-8
0%
NR
39-42% overweight BM,D,E
yes
yes
G, unclear if I
12 mo
unclear, approx 26
NR
NR
Epstein, 199492   44 families
USA
8-12
26%
NR
59.6% over the 50th%ile for BMI  BM,D,E
yes
yes
unclear
1 yr
32
NR
NR
Epstein, 199593  61 families
USA
8-12
27%
4%
51.8% overweight BM,D,E
yes
yes
I + G
6 mo
18
NR
NR
Epstein, 200094  90 families
USA
8-12
32%
NR
62% overweight BM,D,E
yes
yes
I + G
6 mo
20
45-60 min
900-1200 min
Epstein, 200095/
Epstein, 200196
67 children
USA
NR, mean (sd) 10.3 (1.1) yrs
48%
4% 
BMI 27.4 kg/m2(3.2) BM,D,E
yes
yes
I + G
6 mo
18
45-60 min
810-1080 min
Epstein, 200196  67 families
USA
8-12
52%
NR
60.2% overweight (compared to the 50%ile BMI for age and sex);
BMI 27.4 kg/m2 (3.6 kg/m2)
BM, D,E
yes
yes
I + G
6 mo
20
30 min
600 min
Flodmark, 199397 44 children (plus 50 matched controls)
Sweden
10-11
48%
NR (Swedish)
24.7 kg/m2 (family therapy group);
25.5 kg/m2(conventional treatment group);
 25.1 kg/m2(control group)
D,E
no
yes
I
14-18 mo
5 + 6 family therapy sessions
NR
NR
Golan, 199898 60 children
Israel
6-11
38%
NR (Israeli)
39.1% overweight  (conventional group);
39.6% (parents agents of change group)
BM,D,E
yes
noa
G+I
1 yr
30
60 min
1800 min
Graves, 198899  40 children
USA
6-12
NR
NR
52%-56% overweight  BM,D,E
yes
yes
G
8 wk
8
60 min
480 min
Israel, 1985100 33 children
USA
8-12
30%
NR
45.88% overweight (parent training group);
53.13%  (BT only); 56.02% (controls)
BM,D,E
yes
yes
G
12 mo
17
same +2-60 min sessions
>930 min
Israel, 1994101 36 families
USA
8-13
NR
NR
48.1% overweight (enhanced child involvement group);
46.0% (standard treatment group)
BM,D,E
yes
yes
G
26 wk
17
90 min
1530 min
Kang, 2002103/
Gutin, 2002102 
80
USA
13-16
33%
69%
40.7% body fat (white boys); 45.8% body fat (white girls); 43.9% body fat (black boys); 45.2% body fat (black girls) BM,E
no
no
G
8 mo
160
60 min for LSE,
variable for PA
NR
Mellin, 1987104  66 adolescents
USA
12-18
21%
22%
30-37% overweight BM,D,E
yes
yes
G
14 wk
16
90 min
1440 min
Saelens, 2002105  44
USA
12-16
59%
30%
BMI 30.7kg/m2 (3.1) BM,D,E
yes
no
I
4 mo
13
10-20 min for TC, NR for visit
NR, > 200 min
Senediak, 1985106  45 children
USA
6-13
approximately 66%
NR
37.22% overweight BM,D,E
yes
yes
G
4 wk
8
90 min
720 min
Wadden, 1990107  47 girls
USA
12-16
0%
100% black
95.1 kg;
BMI 35.6 kg/m2
BM,D,E
yes
yes
G
10 mo
22
60 min (first 16 sessions), others NR
>960 min
White, 2003108/
Williamson, unpublished data
57 adolescents
USA
11-15
0%
100%
BMI 36.34 kg/m2;
98.3 BMI %ile
BM,D,E
yes
yes
I  
6 mo
4 + weekly Web site logins
NR
NR

 

Study Reference Group Units of Measure Study Duration Outcome at Latest Followup Time P Value for Comparisons Between Groupsb Other Outcomes
USPSTF Quality Grade
Berkowitz, 200386  Sibutramine change in BMI (% change from entry BMI) 6 months -8.5% p = 0.001 P, A Good
Placebo -4.0%
Duffy, 199387 BT + cognitive self-management % overweight change 6 months -8.9% n.s. B Fair-to-Poor
BT + relaxation placebo -9.2%
Ebbeling, 200388  Reduced glycemic load diet absolute change in BMI 12 months -1.2 kg/m2 p < 0.05 B, P Fair
Reduced fat diet 0.6 kg/m2
Epstein, 198589 Lifestyle PA % overweight change 24 months -18.0% <0.05, lifestyle PA vs. Aerobic PA;
<0.05, lifestyle PA vs. calisthenics PA
B, P Fair
Aerobic PA -6.8%
Low-intensity calisthenics PA -7.2%
Epstein, 198590  Diet + PA % overweight change 12 months -25.4% n.s. B, P Fair
Diet alone -18.7%
Epstein, 198591   BT % overweight change 12 months -26.3% <0.05 B Fair
Education only -11.2%
Epstein, 199492 Mastery criteria & contingent reinforcement group % overweight change 24 months -15.4% n.s. B Fair
Comparison group -10.6%
Epstein, 199593  Combined % overweight change 12 months -8.7% p < 0.05, combined vs. increased PA B, P Fair
Decreased SB -10.3%
 Increased PA -18.7%
Epstein, 200094  Decreased SB high dose % overweight change 24 months -14.3% n.s. B, P Fair
Decrease SB low dose -11.6%
PA high dose -13.2%
PA low dose -12.4%
Epstein, 200095/
Epstein, 200196
PS to parent and child change in BMI z-score 24 months -0.5 p < 0.05, PS to parent and child vs. no PS;
p < 0.05, PS to parent and child vs. PS to child only 
H, A Fair
PS to child only -0.9
No PS -1.1
Epstein, 200196  Increased PA change in absolute BMI (statistical comparisons done on percent overweight change) 12 months girls: -0.27 kg/m2;
boys: -0.65 kg/m2
p < 0.01, interaction of group by sex;
p < 0.001, boys in combined group vs. girls in combined group
p < 0.05, boys in combined group vs. girls in increased PA group
none Fair
Combined increased PA + decreased SB  girls: 1.0 kg/m2; boys: -1.76 kg/m2
Flodmark, 199397 Family therapy change in BMI (kg/m2) 26-30 months 1.1 kg/m2 p < 0.05, family therapy vs. untreated controls P Fair
Conventional treatment 1.6 kg/m2
Matched controls, untreated 2.8 kg/m2
Golan, 199898 Conventional: children responsible for own wt loss % overweight change 12 months -8.1% p < 0.05 none Fair
Parents exclusive agents of change -14.7%
Graves, 198899  BT + parent PS % overweight change 6 months -24.5% p < 0.05, PS vs BT only;
p < 0.05, PS vs. instruction only
B Fair
BT only -10.2%
Instruction only -9.5%
Israel, 1985100 BT + parent training in child management % overweight change 12 months -10.2% p < 0.001 per NHS review B Fair-to-Poor
BT only -1.3%
Wait list controls NR
Israel, 1994101 Enhanced child involvement % overweight change 36 months -4.8% n.s. none Fair-to-Poor
Standard treatment (parents primarily responsible) 6.4%
Kang, 2002103/
Gutin, 2002102 
LSE + high intensity PA change in % body fat 8 months -2.9% n.s. B, P Fair-to-Poor
LSE + moderate PA -1.4%
LSE -0.1%
Mellin, 1987104  SHAPEDOWN group (Cognitive, behavioral, affective treatment) % overweight change 15 months -9.9% Between group comparison NR
(15 months vs. baseline: p < 0.01, SHAPEDOWN; n.s., control group)
B, H Fair
No treatment controls -0.1%
Saelens, 2002105  Healthy habits intervention % overweight change & change in BMI (statistical analyses on BMI z-scores) 7 months -2.4%, 0.1 kg/m2 n.s. B, A Good
Typical care 4.1%, 1.4 kg/m2
Senediak, 1985106  Rapid schedule BT % overweight change 6 months -14.7%  p < 0.05, rapid and gradual schedule BT groups combined vs. non-specific controls;
 (comparison of rapid vs. gradual schedule BT groups n.s.)
B Fair-to-Poor
Gradually decreasing schedule BT -18.3%
Non-specific treatment controls -10.9%
 Wait list controls NR
Wadden, 1990107  Mother and child together change in weight 6 months 1.7 kg n.s. P, H Fair-to-Poor
Child alone 3.0 kg
Mother and child separate 3.5 kg
White, 2003108/
Williamson, unpublished data
Behavioral change in % body fat; change in BMI 6 months -1.12%; -0.19 kg/m2 p < 0.05 (% body fat); p < 0.05 (change in BMI) B Good
Education only 0.43%; 0.65 kg/m2

aFor most intensive intervention which is listed first.
bIf multiple comparisons, then presented only if p < 0.05.
Notes: Intervention characteristics: BM = behavior modification; D = special diet; E = exercise program; G = group; I = individual.
Other outcomes: B = behavioral ; p = physiological; H = childhood health outcomes; A = adverse effects.

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