Trial Outcomes & Findings for Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI) (NCT NCT00132132)

NCT ID: NCT00132132

Last Updated: 2015-05-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline, 12-15 months
• Results posted on: 2015-05-21

Participant Flow

Participant milestones

Measure	Behavioral Program This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).	Standard of Care/Control Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
Overall Study STARTED	15	15
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Measure	Behavioral Program This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).	Standard of Care/Control Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
Overall Study Lost to Follow-up	7	2

Baseline Characteristics

Study of Impact of Behavioral Intervention- Exercise, Nutrition, Education- on Body Mass Index (BMI)

Baseline characteristics by cohort

Measure	Behavioral Program n=15 Participants This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).	Standard of Care/Control n=15 Participants Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	11 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	15 participants n=4 Participants	30 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 12-15 months

Population: Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment

Outcome measures

Measure	Intervention Group n=8 Participants The intervention group attended monthly, 4 hour sessions for one year	Standard of Care/Control Group n=13 Participants The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
Change in BMI (Body Mass Index) Unadjusted per-protocol change in BMI	-0.74 kg/m^2 Interval -2.21 to 0.72	1.33 kg/m^2 Interval 0.18 to 2.48
Change in BMI (Body Mass Index) Adjusted for age per-protocol change in BMI	-0.18 kg/m^2 Interval -1.4 to 1.04	0.98 kg/m^2 Interval 0.04 to 1.93
Change in BMI (Body Mass Index) Adjusted for age/paternal education change in BMI	-0.37 kg/m^2 Interval -1.19 to 0.44	1.28 kg/m^2 Interval 0.59 to 1.97

PRIMARY outcome

Timeframe: Baseline, 12-15 months

Population: Per protocol

Outcome measures

Measure	Intervention Group n=8 Participants The intervention group attended monthly, 4 hour sessions for one year	Standard of Care/Control Group n=13 Participants The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
Percentage of Participants With BMI Reduction	75 percentage of participants	23 percentage of participants

Adverse Events

Behavioral Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care/Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shirley Gonzalez

SEMC

Phone: 617-926-0114

Email: shirley.gonzalez@steward.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place