Adolescent ObesityNCT01139411
The Role of Parents in Adolescent Weight Loss
A study of Adolescent Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Adolescent Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 30 and 90% overweight
- Parent or guardian willing to participate
Who cannot join
- Major psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parental Involvement as a Strategy to Enhance Adolescent Weight Control
The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement.
- Conditions
- Adolescent Obesity
- Being tested
- Behavioral Weight Control with Enhanced Parent Involvement, Behavioral Weight Control with Minimal Parent Involvement
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Control with Enhanced Parent InvolvementBehavioural
Behavioral Weight Control with Minimal Parent InvolvementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Control with Enhanced Parent Involvement | Experimental | This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control. Receives: Behavioral: Behavioral Weight Control with Enhanced Parent Involvement |
| Behavioral Weight Control with Minimal Parent Involvement | Placebo comparator | This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Receives: Behavioral: Behavioral Weight Control with Minimal Parent Involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Post-treatment BMI (controlling for baseline BMI)
Measured: Baseline and at completion of 16 week intervention
Secondary outcomes (6)
Parent Modeling 1: Dietary Choices (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.
Measured: Baseline to post-treatment
Parent Modeling 2: Self-monitoring (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.
Measured: Baseline to post-treatment
Parent Modeling 3: Physical Activity (WCSS)
Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.
Measured: Baseline to post-treatment
Parent Modeling 4: Weight and Body Concerns (FERF-Q)
Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.
Measured: Baseline to post-treatment
Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.
Measured: Baseline to post-treatment
Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.
Measured: Baseline to post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elissa Jelalian, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139411
- Sponsor's protocol ID
- GRANT00538804
- Other IDs
- R03HD060137
- Status last verified
- Aug 2016
- First submitted
- 7 Jun 2010
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Involvement as a Strategy to Enhance Adolescent Weight Control
- ClinicalTrials.gov ID
- NCT01139411
- Acronym / sponsor ID
- GRANT00538804
- Conditions
- Adolescent Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Posted 30 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Control with Enhanced Parent Involvement | Experimental | Behavioral: Behavioral Weight Control with Enhanced Parent InvolvementThis treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control. |
| Behavioral Weight Control with Minimal Parent Involvement | Placebo comparator | Behavioral: Behavioral Weight Control with Minimal Parent InvolvementThis treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Between 30 and 90% overweight
- Parent or guardian willing to participate
Key exclusion criteria (1 listed)
- Major psychiatric disorder
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 |
|---|---|---|
| Behavioral Weight Control with Enhanced Parent Involvement | Behavioural | Behavioral Weight Control with Enhanced Parent Involvement |
| Behavioral Weight Control with Minimal Parent Involvement | Behavioural | Behavioral Weight Control with Minimal Parent Involvement |
Primary outcome
Body Mass Index
Time frame: Baseline and at completion of 16 week intervention
Post-treatment BMI (controlling for baseline BMI)
6 secondary outcomes
Parent Modeling 1: Dietary Choices (WCSS)
Time frame: Baseline to post-treatment
Parent Modeling 2: Self-monitoring (WCSS)
Time frame: Baseline to post-treatment
Parent Modeling 3: Physical Activity (WCSS)
Time frame: Baseline to post-treatment
Parent Modeling 4: Weight and Body Concerns (FERF-Q)
Time frame: Baseline to post-treatment
Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
Time frame: Baseline to post-treatment
Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
Time frame: Baseline to post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Adolescent Obesity, run by The Miriam Hospital 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 2 inclusion and 1 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 30 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Mass Index (time frame: Baseline and at completion of 16 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2016.