Pediatric ObesityTEENS+NCT02586090
The Role of Parents in Adolescent Obesity Treatment
A study testing Parents as Coaches and Parent Weight Loss in people with Pediatric Obesity, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Parents as Coaches and Parent Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2016to 19 Feb 2018
- Phase
- Interventional
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescent Inclusion Criteria:
- BMI ≥85% percentile for age and gender according to the CDC Growth Charts
- Age 12 to 16
- must reside with the primary participating parent
- parent must have a BMI ≥25 kg/m 2
- parent must be willing to participate in the protocol
Show all 10Show fewer
- Parent Inclusion Criteria:
- 18-60 years of age
- BMI ≥25 kg/m2
- must reside with the adolescent
Who cannot join
- Adolescent Exclusion Criteria
- non-English speaking
- medical condition(s) that may be associated with unintentional weight change
- use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
- medical condition(s) that may be negatively impacted by exercise
- psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity
Show all 26Show fewer
- reports of compensatory behaviors in the past 3 months
- current pregnancy or plan to become pregnant during study period
- previous participation in HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
- current participation in another weight loss program; or 11) personal history of weight loss surgery.
- clinically significant depression
- clinically significant eating disorder
- change in dose of metformin, oral contraceptives, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications within 3 months prior to study participation.
- weight in excess of 400 pounds
- admission to a psychiatric hospital within the past year
- Parent Exclusion Criteria
- non-English speaking
- medical condition(s) that may be associated with unintentional weight change
- use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or investigational medications within 3 months of study participation
- psychiatric, cognitive, physical or developmental conditions that would impair the parent's ability to respond to assessments, participate in physical activity or participate in a group
- reports of compensatory behaviors in the past 3 months
- current pregnancy, lactation, less than 6 months post-partum, or plan to become pregnant during the study period
- past participation in IRB3354, HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
- currently engaged in another weight loss program, or 9) personal history of weight loss surgery.
- Severe depression or endorsing suicidal thoughts
- admission to a psychiatric hospital within the past year.
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
Official title: Innovative Approaches to Adolescent Obesity Treatment: Exploring the Role of Parents
The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents.
Read the detailed description
Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and parent(s) (BMI >25 kg/m2). Families will participate in one of two 4-month treatments: 1) TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in TEENS+, which includes behavioral support, nutrition education, and supervised physical activity.
For the adolescents, intervention will consist of weekly 1 hour exercise sessions and alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL). Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.
- Conditions
- Pediatric Obesity
- Being tested
- Parents as Coaches, Parent Weight Loss
- Keywords
- Pediatric Obesity, Lifestyle Intervention, Family-based Intervention, Motivational Interviewing
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents as CoachesBehavioural
PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.
Parent Weight LossBehavioural
In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program
| Study group | Role | What they receive |
|---|---|---|
| Parents as Coaches | Active comparator | PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. Receives: Behavioral: Parents as Coaches |
| Parent Weight Loss | Experimental | In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program Receives: Behavioral: Parent Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group differences in parent weight change.
Weight change (kg; parents)- primary outcome; trial is powered on parent weight change
Measured: 4 months (pre-intervention - post-test)
Within group differences in adolescent changes in BMI
BMI change (kg/m2; adolescent)
Measured: 4 months (pre-intervention - post-test)
Secondary outcomes (5)
Changes in parent dietary intake
Average total energy intake (kcal/day) estimated via 3-day food record
Measured: 4 months (pre-intervention - post-test)
Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire
parenting and feeding style
Measured: 4 months (pre-intervention - post-test)
Changes in child dietary intake
Average total energy intake (kcal/day) estimated via 3-day food record
Measured: 4 months (pre-intervention - post-test)
Changes in parent physical activity
Mean total daily energy expenditure (kcal/day) estimated via accelerometer
Measured: 4 months (pre-intervention - post-test)
Changes in adolescent physical activity
Mean total daily energy expenditure (kcal/day) estimated via accelerometer
Measured: 4 months (pre-intervention - post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start6 Jan 2016
- Primary completion17 Feb 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Melanie Bean, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586090
- Sponsor's protocol ID
- HM20005235
- Other IDs
- 1R21HD084930
- Acronym
- TEENS+
- Status last verified
- May 2023
- First submitted
- 16 Jul 2015
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approaches to Adolescent Obesity Treatment: Exploring the Role of Parents
- ClinicalTrials.gov ID
- NCT02586090
- Acronym / sponsor ID
- TEENS+ / HM20005235
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric Obesity, Lifestyle Intervention, Family-based Intervention, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 17 Feb 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 26 Oct 2015 (estimated)
- 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.
The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents.
Detailed description
Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and parent(s) (BMI >25 kg/m2). Families will participate in one of two 4-month treatments: 1) TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in TEENS+, which includes behavioral support, nutrition education, and supervised physical activity.
For the adolescents, intervention will consist of weekly 1 hour exercise sessions and alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL). Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents as Coaches | Active comparator | Behavioral: Parents as CoachesPAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. |
| Parent Weight Loss | Experimental | Behavioral: Parent Weight LossIn PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- BMI ≥85% percentile for age and gender according to the CDC Growth Charts
- Age 12 to 16
- must reside with the primary participating parent
- parent must have a BMI ≥25 kg/m 2
- parent must be willing to participate in the protocol
Key exclusion criteria (26 listed)
- Adolescent Exclusion Criteria
- non-English speaking
- medical condition(s) that may be associated with unintentional weight change
- use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
- medical condition(s) that may be negatively impacted by exercise
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 |
|---|---|---|
| Parents as CoachesPAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. | Behavioural | Parents as Coaches |
| Parent Weight LossIn PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program | Behavioural | Parent Weight Loss |
Primary outcome
Between-group differences in parent weight change.
Time frame: 4 months (pre-intervention - post-test)
Weight change (kg; parents)- primary outcome; trial is powered on parent weight change
Within group differences in adolescent changes in BMI
Time frame: 4 months (pre-intervention - post-test)
BMI change (kg/m2; adolescent)
5 secondary outcomes
Changes in parent dietary intake
Time frame: 4 months (pre-intervention - post-test)
Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire
Time frame: 4 months (pre-intervention - post-test)
Changes in child dietary intake
Time frame: 4 months (pre-intervention - post-test)
Changes in parent physical activity
Time frame: 4 months (pre-intervention - post-test)
Changes in adolescent physical activity
Time frame: 4 months (pre-intervention - post-test)
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 31 May 2023.
- Individual participant dataSharing planned: No
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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 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?
A study testing Parents as Coaches and Parent Weight Loss in people with 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 10 inclusion and 26 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 31 May 2023. 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?
Between-group differences in parent weight change. (time frame: 4 months (pre-intervention - post-test)). The study lists 2 primary outcomes in all. 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 31 May 2023.