Exploring the Familial Reach of Adolescent Obesity Treatment
NCT ID: NCT05780970
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2022-01-18
2024-06-29
Brief Summary
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Funding support from NIH via R21HD105906.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No intervention
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).
Interventions
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No intervention
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).
Eligibility Criteria
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Inclusion Criteria
* Untreated caregiver: must be 18 years of age or older and primarily living in the same household as the TEENS+ participants.
* Treated caregivers: must have another individual in the household that meets the eligbility for an untreated child or untreated caregiver.
Exclusion Criteria
* children with a BMI\<5th%ile or caregivers with a BMI\<18.5 kg/m2
* non-English speaking
* medical condition(s) that may be associated with unintentional weight change or significant disruption to eating behaviors (e.g., hypothalamic injury, Prader-Willi, G-tube placement, or malignancy
* clinically significant eating disorder (e.g., anorexia nervosa or bulimia nervosa)
* following a medically-supervised/prescribed diet
* psychiatric, cognitive, physical or developmental conditions that would impair the individual's ability to complete assessments.
8 Years
ALL
No
Sponsors
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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)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Melanie K Bean, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Children's Hospital of Richmond at VCU Healthy Lifestyles Center
Henrico, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HM20014304 Phase 3
Identifier Type: -
Identifier Source: org_study_id
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