Exploring the Familial Reach of Adolescent Obesity Treatment

NCT05780970 | Completed DMC

• 2 other identifiers: HM20014304 Phase 3R21HD105906
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Obesity

Keywords

Pediatric Obesity; Lifestyle Intervention; Family-Level Change; Family-based Intervention

Outcome Measures

Primary Outcomes (3)

• 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)]

Study Arms (1)

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.

Other: No intervention

Interventions

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).

Non-targeted individuals

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Untreated children: must be between 8-17 years of age and primarily living in the same household as the TEENS+ participants.
• 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.

You may not qualify if:

• temporarily (\<1yr) living in the home
• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of Connecticut: collaborator
• University of North Carolina: collaborator
• University of Tennessee: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

Location

Related Publications (1)

• 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.

  PMID: 38404649 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie K Bean, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: January 18, 2022
• Primary Completion: June 29, 2024
• Study Completion: June 29, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

US (1)