Obesity, Childhood
Conditions
Keywords
obesity
Brief summary
The goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.
Detailed description
The proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing BMI among overweight and obese 8-12 year olds seen in pediatric practice: (1) Fitline-Coaching, consisting of a pediatric practice-based component plus Fitline counseling and workbook, or (2) Fitline-Workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to Fitline coaching. Sixteen pediatric primary care practices will be randomized to either the Fitline-Coaching (N=8) or the Fitline-Materials (N=8) condition. Five hundred and twelve parents and their children ages 8-12 with a body mass index (BMI) of \> 85th percentile (overweight or obese) will be recruited from the practices to achieve N=400 at 12 month follow-up.
Interventions
BEHAVIORALCoaching
The eight weekly 30-minute Fitline calls provide personalized behavioral counseling and coaching to guide parents in improving their child's weight-related behaviors through targeted lifestyle changes recommended by the AAP for Stage 1, Prevention Plus. Calls are scheduled at a time convenient for the parent, including nights and weekends, with one nutritionist assigned to a family for consistency.
BEHAVIORALMaterials
The workbook contains tips and practical strategies for implementing the AAP-recommended behavior changes discussed in the counseling sessions to support families in making lifestyle changes.
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
1. child BMI \>= 85th percentile for age/sex, 2. participating parent and child English speaking, 3. parent has access to a telephone and is available to participate in telephone counseling sessions, and 4. referred by the child's primary care provider.
Exclusion criteria
1. planning to move out of the area during the period of study participation, 2. medical condition that precludes adherence to AAP dietary and physical activity recommendations, 3. genetic or endocrine causes of obesity, 4. prescribed medications associated with weight gain, 5. child on psychiatric medications, and/or 6. morbidly obese (\> 300 pounds). -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reducing BMI in overweight and obese children. | Baseline and 12-months post-baseline | BMI will be calculated from weight (kg)/height squared (in meters) and BMI z-score for age/sex will be determined using CDC growth charts for the child. It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater reductions in BMI z-scores at 12-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improving the child's diet | Baseline and 6-months post-baseline | It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in diet at 6-month follow-up. This will be measured by 24 hour dietary recalls conducted 3 times at each time point. |
| Improving the child's physical activity | Baseline and 6-months post-baseline | It is hypothesized that the Fitline-Coaching group compared to the Fitline-Workbook group will have greater improvements in their level of physical activity at 6-month follow-up. This will be measured by the Physical Activity Questionnaire (PAQ-C). |
| Effect of the Fitline-Coaching on BMI through a composite measure of Social Cognitive Theory constructs | Baseline and 6-months post-baseline | It is hypothesized that the effect of the Fitline-Coaching on child BMI will be predicted by changes in Social Cognitive Theory constructs. Parents will complete a survey assessing: (1) anticipated benefits of the behavior change (outcome expectations) (23-item questionnaire); (2) perceived support and barriers to addressing their child's behavior changes (15-item questionnaire); (3) self efficacy in helping their child improve their diet and physical activity (12-item) questionnaire; (4) behavioral capability (12-item questionnaire); and (5) knowledge (7-item questionnaire). Children will complete a survey assessing (1) anticipated benefits of the behavior change (outcome expectations) (23-item questionnaire); (2) perceived support and barriers (67-item questionnaire); (3) self efficacy (16-item questionnaire); (4) behavioral capability (12-item questionnaire); and (5) knowledge (7 item questionnaire). |
| Cost Effectiveness | Baseline and 12-months post-baseline | Costs and health outcomes will be compared across conditions. Costs will include those of: (1) provider training and intervention, (2) office set-up and support, (3) intervention materials, and (4) Fitline coaching. The outcome will be change in BMI z-score. |
Countries
United States
Outcome results
None listed