CClinicalTrials.gg
CompletedNCT05780970Updated Oct 2, 2024

Exploring the Familial Reach of Adolescent Obesity Treatment

An observational study in Pediatric Obesity, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by Virginia Commonwealth University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
8 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Pediatric Obesity

Keywords

  • Pediatric Obesity
  • Lifestyle Intervention
  • Family-Level Change
  • Family-based Intervention
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 55 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo 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).

06

What researchers measure

Primary outcomes

  1. Family-level changes to the shared home environment.

    Changes in the home food available and the home exercise and electronic media environment.

    Time frame: 4 months (baseline to 4 months)

  2. Weight changes.

    Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss)

    Time frame: 4 months (baseline to 4 months)

  3. Household changes and target adolescent weight.

    Associations between household changes and target adolescent weight loss and maintenance.

    Time frame: 8 months [weight loss (baseline to 4 months) and maintenance (4-8)]

07

Study locations

1 site
  • Children's Hospital of Richmond at VCU Healthy Lifestyles Center
    Henrico, Virginia 23239, United States
08

References and documents

Study documents

  • Informed consent form · Mar 30, 2023

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05780970
Lead sponsor
Virginia Commonwealth University
Collaborators
University of Connecticut, University of North Carolina, University of Tennessee, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Mar 23, 2023
Start date
Jan 18, 2022
Primary completion
Jun 29, 2024
Completion
Jun 29, 2024
Last update
Oct 2, 2024

Study contacts

Melanie K Bean, PhD
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion