Obesity
Conditions
Keywords
BMI, obesity, behavioral intervention, longterm randomized controlled trial, exercise, empowerment, nutrition
Brief summary
This study will evaluate the impact a behavioral intervention can have on BMI. The researchers anticipate the intervention group will experience a decrease in BMI of approximately five points. The intervention group will be compared to a control group. This is a long term, randomized, controlled study. The behavioral intervention is conducted during a four hour monthly session. The behavioral intervention includes: exercise, education on medical aspects and nutrition, and empowerment.
Detailed description
This is a long term randomized controlled trial, looking at the impact of a behavioral intervention on BMI,in participants ages 10-20 with a BMI \> 85%. The intervention group will: * have baseline and follow up blood work (fasting insulin, glucose, lipid panel) * have baseline and follow up BMI, blood pressure measurements * see a dietician-minimum of three visits during study * attend monthly, four hour sessions. These sessions include: 1. registration-monitoring of choices of liquid intake using standardized models, monitoring of sedentary behaviors-hours watching television, computer, video games, monitoring of heart rate at baseline and after exercise, monitoring of METs (metabolic equivalents), motivational interviewing, monitoring of exercise abilities (endurance, agility, curl ups, balance, power) 2. one hour of exercise (including strength training) 3. educational lectures on nutrition and the medical aspects of obesity and Type 2 diabetes epidemic 4. projects/games 5. empowerment tools such as leading exercises and presenting food labels for discussion The control group will have: 1. baseline and follow up blood work (fasting insulin, glucose, lipid panel) 2. baseline and follow up BMI and blood pressure measurements 3. visits to dietician (minimum of three visits during study) 4. standard education on nutrition and exercise given during office visit with primary care doctor
Interventions
BEHAVIORALBehavioral education program
Monthly 4 hr session which incorporates: exercise, empowerment, education, and incentives
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 10-20 years * BMI\>85%
Exclusion criteria
* Endocrine disorder * On psychotropic medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BMI (Body Mass Index) | Baseline, 12-15 months |
| Percentage of Participants With BMI Reduction | Baseline, 12-15 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 15 |
| Standard of Care/Control Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 2 |
Baseline characteristics
| Characteristic | Behavioral Program | Standard of Care/Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in BMI (Body Mass Index)
Time frame: Baseline, 12-15 months
Population: Per protocol analysis: subjects who attended at least one intervention session in addition to their final assessment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Group | Change in BMI (Body Mass Index) | Unadjusted per-protocol change in BMI | -0.74 kg/m^2 |
| Intervention Group | Change in BMI (Body Mass Index) | Adjusted for age per-protocol change in BMI | -0.18 kg/m^2 |
| Intervention Group | Change in BMI (Body Mass Index) | Adjusted for age/paternal education change in BMI | -0.37 kg/m^2 |
| Standard of Care/Control Group | Change in BMI (Body Mass Index) | Unadjusted per-protocol change in BMI | 1.33 kg/m^2 |
| Standard of Care/Control Group | Change in BMI (Body Mass Index) | Adjusted for age per-protocol change in BMI | 0.98 kg/m^2 |
| Standard of Care/Control Group | Change in BMI (Body Mass Index) | Adjusted for age/paternal education change in BMI | 1.28 kg/m^2 |
p-value: 0.03t-test, 2 sided
p-value: 0.14t-test, 2 sided
p-value: 0.006t-test, 2 sided
Primary
Percentage of Participants With BMI Reduction
Time frame: Baseline, 12-15 months
Population: Per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Percentage of Participants With BMI Reduction | 75 percentage of participants |
| Standard of Care/Control Group | Percentage of Participants With BMI Reduction | 23 percentage of participants |
p-value: 0.02Chi-squared