Pediatric ObesityNCT05780970
Exploring the Familial Reach of Adolescent Obesity Treatment
An observational study of Pediatric Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Pediatric Obesity
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 29 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Richmond at VCU Healthy Lifestyles Center
Henrico, Virginia, 23239
About this study
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.
- Conditions
- Pediatric Obesity
- Being tested
- No intervention
- Keywords
- Pediatric Obesity, Lifestyle Intervention, Family-Level Change, Family-based Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family-level changes to the shared home environment.
Changes in the home food available and the home exercise and electronic media environment.
Measured: 4 months (baseline to 4 months)
Weight changes.
Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss)
Measured: 4 months (baseline to 4 months)
Household changes and target adolescent weight.
Associations between household changes and target adolescent weight loss and maintenance.
Measured: 8 months [weight loss (baseline to 4 months) and maintenance (4-8)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start18 Jan 2022
- Primary completion29 Jun 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Melanie K Bean, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780970
- Sponsor's protocol ID
- HM20014304 Phase 3
- Other IDs
- R21HD105906
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38404649
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Familial Reach of Adolescent Obesity Treatment
- ClinicalTrials.gov ID
- NCT05780970
- Acronym / sponsor ID
- HM20014304 Phase 3
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric Obesity, Lifestyle Intervention, Family-Level Change, Family-based Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- University of Connecticut, University of North Carolina, University of Tennessee, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-targeted individuals | – | Other: No interventionNon-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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNon-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). | Other | Non-targeted individuals |
Primary outcome
Family-level changes to the shared home environment.
Time frame: 4 months (baseline to 4 months)
Changes in the home food available and the home exercise and electronic media environment.
Weight changes.
Time frame: 4 months (baseline to 4 months)
Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss)
Household changes and target adolescent weight.
Time frame: 8 months [weight loss (baseline to 4 months) and maintenance (4-8)]
Associations between household changes and target adolescent weight loss and maintenance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 38404649Brown 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie K Bean, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family-level changes to the shared home environment. (time frame: 4 months (baseline to 4 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.