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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD084930 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents.
Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and parent(s) (BMI >25 kg/m2). Families will participate in one of two 4-month treatments: 1) TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in TEENS+, which includes behavioral support, nutrition education, and supervised physical activity.
For the adolescents, intervention will consist of weekly 1 hour exercise sessions and alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL). Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parents as Coaches | Active Comparator | PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. |
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| Parent Weight Loss | Experimental | In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parents as Coaches | Behavioral | PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group differences in parent weight change. | Weight change (kg; parents)- primary outcome; trial is powered on parent weight change | 4 months (pre-intervention - post-test) |
| Within group differences in adolescent changes in BMI | BMI change (kg/m2; adolescent) | 4 months (pre-intervention - post-test) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in parent dietary intake | Average total energy intake (kcal/day) estimated via 3-day food record | 4 months (pre-intervention - post-test) |
| Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire |
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Inclusion Criteria:
Adolescent Inclusion Criteria:
Parent Inclusion Criteria:
Exclusion Criteria:
Adolescent Exclusion Criteria
Parent Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Bean, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Richmond at VCU Healthy Lifestyles Center | Henrico | Virginia | 23239 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Consent Form | Nov 16, 2016 | May 26, 2023 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent Form | Nov 16, 2016 | May 26, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Assessors blind to hypotheses and allocation Interventionsts blinded to hypotheses
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| Parent Weight Loss | Behavioral | In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program |
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parenting and feeding style |
| 4 months (pre-intervention - post-test) |
| Changes in child dietary intake | Average total energy intake (kcal/day) estimated via 3-day food record | 4 months (pre-intervention - post-test) |
| Changes in parent physical activity | Mean total daily energy expenditure (kcal/day) estimated via accelerometer | 4 months (pre-intervention - post-test) |
| Changes in adolescent physical activity | Mean total daily energy expenditure (kcal/day) estimated via accelerometer | 4 months (pre-intervention - post-test) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |