Pediatric ObesityNCT02262013
Evaluation of a Family-based Pediatric Obesity Program: TEENS+
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
Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the feasibility of this dietary intervention strategy and preliminary effectiveness of two models of parental involvement within adolescent obesity treatment. Read more about this study
- Who is it for?
- Ages 12 to 17 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Sep 2016
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Adolescents and parents will be ineligible for study participation under the following conditions: 1) non-English speaking; 2) medical condition(s) that may be associated with unintentional weight change (e.g., hypothalamic injury, Prader-Willi, or malignancy); 3) diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with glucose intolerance or "pre-diabetes" will eligible for study participation); 4) use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation; 5) medical condition(s) that may be negatively impacted by exercise; 6) physical limitation affected the ability to exercise, 7) psychiatric, cognitive or developmental conditions that would impair the adolescent's ability to complete assessments or participate in a group; 8) reports of compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3 months; 9) current pregnancy or plan to become pregnant during study period; 10) previous participation in TEENS or NOURISH; 11) current participation in another weight loss program; or 12) personal history of weight loss surgery.
- Adolescents and parents taking metformin, oral contraceptives, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications may be eligible for participation; however, subjects must be on a stable dose of medication for at least 3 months prior to study participation.
- In addition, adolescents will be excluded from participation (and referred for further evaluation) based on the results of baseline psychological assessments under the following circumstances: 1) clinically significant depression, evidenced by elevations (>20) on CDI; 2) suicidality as reported on CDI or during screening / behavioral interview; 3) psychosis, 4) clinical impairment in Activities of Daily Living and Functional Communication (i.e., expressive and receptive communication; and 3) clinically significant eating disorder based on EDE-Q.
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
Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the feasibility of this dietary intervention strategy and preliminary effectiveness of two models of parental involvement within adolescent obesity treatment.
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 6-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, lab work, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3 months, 6 months (post-intervention), and 9 months.
- 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
Also called TEENS+PAC
Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.
Parent Weight LossBehavioural
Also called TEENS+PWL
Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.
| 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.
Change in BMI z-scores (adolescents and parents)
Measured: 3 months, 6 months, 9 months
Secondary outcomes (6)
Changes in Insulin Sensitivity
Insulin, Glucose, HbA1c
Measured: 6 months, 9 months
Changes in Serum Lipids
Measured: 6 months, 9 months
Changes in Energy Balance
Adipokines, Cytokines
Measured: 6 months, 9 months
Changes in Blood Pressure
Measured: 3 months, 6 months, 9 months
Changes in Psychosocial Measures
Measured: 3 months, 6 months, 9 months
Changes in Dietary Intake
Measured: 3 months, 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2016
- Study completionSep 2016
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmond P Wickham, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262013
- Sponsor's protocol ID
- HM20003076
- Status last verified
- Feb 2017
- First submitted
- 7 Oct 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Family-based Pediatric Obesity Program: TEENS+
- ClinicalTrials.gov ID
- NCT02262013
- Acronym / sponsor ID
- HM20003076
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric Obesity, Lifestyle Intervention, Family-based Intervention, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Oct 2014 (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.
Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the feasibility of this dietary intervention strategy and preliminary effectiveness of two models of parental involvement within adolescent obesity treatment.
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 6-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, lab work, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3 months, 6 months (post-intervention), and 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Adolescents and parents will be ineligible for study participation under the following conditions: 1) non-English speaking; 2) medical condition(s) that may be associated with unintentional weight change (e.g., hypothalamic injury, Prader-Willi, or malignancy); 3) diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with glucose intolerance or "pre-diabetes" will eligible for study participation); 4) use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation; 5) medical condition(s) that may be negatively impacted by exercise; 6) physical limitation affected the ability to exercise, 7) psychiatric, cognitive or developmental conditions that would impair the adolescent's ability to complete assessments or participate in a group; 8) reports of compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3 months; 9) current pregnancy or plan to become pregnant during study period; 10) previous participation in TEENS or NOURISH; 11) current participation in another weight loss program; or 12) personal history of weight loss surgery.
- Adolescents and parents taking metformin, oral contraceptives, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications may be eligible for participation; however, subjects must be on a stable dose of medication for at least 3 months prior to study participation.
- In addition, adolescents will be excluded from participation (and referred for further evaluation) based on the results of baseline psychological assessments under the following circumstances: 1) clinically significant depression, evidenced by elevations (>20) on CDI; 2) suicidality as reported on CDI or during screening / behavioral interview; 3) psychosis, 4) clinical impairment in Activities of Daily Living and Functional Communication (i.e., expressive and receptive communication; and 3) clinically significant eating disorder based on EDE-Q.
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 CoachesAlso: TEENS+PACAdolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention. | Behavioural | Parents as Coaches |
| Parent Weight LossAlso: TEENS+PWLAdolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention. | Behavioural | Parent Weight Loss |
Primary outcome
Change in BMI z-scores (adolescents and parents)
Time frame: 3 months, 6 months, 9 months
6 secondary outcomes
Changes in Insulin Sensitivity
Time frame: 6 months, 9 months
Changes in Serum Lipids
Time frame: 6 months, 9 months
Changes in Energy Balance
Time frame: 6 months, 9 months
Changes in Blood Pressure
Time frame: 3 months, 6 months, 9 months
Changes in Psychosocial Measures
Time frame: 3 months, 6 months, 9 months
Changes in Dietary Intake
Time frame: 3 months, 6 months, 9 months
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 10 Feb 2017.
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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.
Edmond P Wickham, MD, MPH 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 0 inclusion and 3 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 10 Feb 2017. 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?
Change in BMI z-scores (adolescents and parents) (time frame: 3 months, 6 months, 9 months). 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 10 Feb 2017.