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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD105906 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Connecticut | OTHER |
| University of North Carolina | OTHER |
| University of Tennessee | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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An observational study ancillary to the randomized clinical trial (RCT) TEENS+ (R01HD095910), a family-based lifestyle intervention, for adolescents with obesity, to determine: 1) if family-wide changes to the shared home environment are implemented, 2) if ripple effects to untreated family members are observed, and 3) whether these changes are predictive of adolescents' weight management success.
Funding support from NIH via R21HD105906.
Investigators will recruit non-targeted children (8-17yrs) and caregivers living in the same household as the target TEENS+ parent/adolescent dyad. At 0, 2, 4 and 8m, the target adolescent/parent dyad (n=60), and non-targeted children and caregivers will complete anthropometric assessments, and measures of the shared home feeding and weight-related environment will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-targeted individuals | Non-targeted children and caregivers living in the same household as the target parent/adolescent dyad. Non-targeted meaning they did not receive the TEENS+ intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Non-treated children and caregivers complete assessments only. The primary (treated) parent / adolescent dyad participate in family based weight management treatment through the main trial. In the main trial, families are randomized to either TEENS+Parents as Coaches (parent skills training) or TEENS+Parent Weight Loss (parent behavioral weight loss). |
| Measure | Description | Time Frame |
|---|---|---|
| Family-level changes to the shared home environment. | Changes in the home food available and the home exercise and electronic media environment. | 4 months (baseline to 4 months) |
| Weight changes. | Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss) | 4 months (baseline to 4 months) |
| Household changes and target adolescent weight. | Associations between household changes and target adolescent weight loss and maintenance. | 8 months [weight loss (baseline to 4 months) and maintenance (4-8)] |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals residing in the home with the parent/child dyad who are participating in the TEENS+ (R01HD095910) RCT. Participating dyads must have overweight or obesity.
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| Name | Affiliation | Role |
|---|---|---|
| Melanie K 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38404649 | Derived | Brown KL, LaRose JG, Raynor HA, Gorin AA, Thornton LM, Farthing S, Tatum K, Bean MK. Study design and rationale for TEENS+REACH: Evaluating ripple effects of a family-based lifestyle intervention to untreated family members. Contemp Clin Trials Commun. 2024 Feb 15;38:101276. doi: 10.1016/j.conctc.2024.101276. eCollection 2024 Apr. |
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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 | Mar 30, 2023 | Sep 30, 2024 | ICF_000.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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| NIH |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |