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Pediatric ObesityTEENS+NCT03851796

Parent Involvement in Adolescent Obesity Treatment

A study testing TEENS+Parents as Coaches and TEENS+Parent Weight Loss in people with Pediatric Obesity, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized control trial to compare the efficacy of two distinct parent treatments on weight loss maintenance for adolescents with obesity participating in a lifestyle intervention including nutrition education, exercise and behavioral support. Funding support from NIH via 1R01HD095910 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?
TEENS+Parents as Coaches and TEENS+Parent Weight Loss
Could I receive a placebo?
No, everyone receives an active treatment
How many people
418 participants
Where
1 siteUnited States
Study dates
23 May 2019to 26 Oct 2024
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 12 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Adolescent Inclusion Criteria:
  • BMI ≥ 85th percentile for age and gender according to the CDC Growth Charts
  • Age 12 to 16
  • Must reside with the primary participating parent
  • Parent Inclusion Criteria:
  • ≥18
  • 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
  • Diabetes mellitus
  • Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation
  • Use of a GLP-1 within 6 months of study participation
Show all 34Show fewer
  • Use of Depo-Provera within 6 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
  • Reports of compensatory behaviors in the past 3 months
  • Current pregnancy or plan to become pregnant during study period
  • Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304
  • Current participation in another weight loss program
  • Personal history of weight loss surgery
  • Severe depression
  • Clinically significant eating disorder
  • Change in dose of metformin, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
  • 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 an investigational medication within 3 months of study participation
  • Use of a GLP-1 within 6 months of study participation with no T2D diagnosis; if T2D diagnosis, change in dose GLP-1 within 3 months of study participation
  • Use of Depo-Provera within 6 months of study participation
  • Psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity
  • Reports of compensatory behaviors in the past 3 months
  • Current pregnancy, lactation, less than 6 months post-partum, or plan to become pregnant during study period
  • Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304
  • Current participation in another weight loss program
  • Personal history of weight loss surgery
  • Severe depression
  • Clinically significant eating disorder
  • Change in dose of diabetes medications, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
  • 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

Other trials in United States

About this study

Official title: The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+

A randomized control trial to compare the efficacy of two distinct parent treatments on weight loss maintenance for adolescents with obesity participating in a lifestyle intervention including nutrition education, exercise and behavioral support.

Funding support from NIH via 1R01HD095910

Read the detailed description

Investigators will recruit adolescents with overweight or obesity (BMI>85th percentile) and a parent (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 adolescents, the intervention will consist of weekly behavioral weight management group sessions and weekly 1 hour exercise sessions. Each adolescent also has a monthly individual session with a behavior coach. Parent groups meet weekly for 1 hour according to treatment arm (PAC or PWL). All PWL sessions are separate from their adolescent. Bi-weekly sessions in the PAC arm are combined with parents and adolescent. Assessments will consist of anthropometric measures, psychological surveys and dietary and PA evaluations. Assessments will be completed at baseline, 2 months, 4 months (post-test), 8 months and 1 year.

Being tested
TEENS+Parents as Coaches, TEENS+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.

  • TEENS+Parents as CoachesBehavioural

    Also called Parents as Champions for TEENS (PACT)

    Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.

  • TEENS+Parent Weight LossBehavioural

    Also called Healthy You!

    Parent Weight loss teaches core behavioral weight loss strategies and techniques for parent weight loss; adolescents are in a group based behavioral weight management treatment.

Study groups in NCT03851796
Study groupRoleWhat they receive
TEENS+Parents as CoachesActive comparatorParents are taught strategies to support and facilitate child weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on strategies to facilitate healthy weight management in their child(ren). Topics include role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. They receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents will receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.
Receives: Behavioral: TEENS+Parents as Coaches
TEENS+Parent Weight LossActive comparatorParents are given a weight loss goal of 1-2 lbs/week, and specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.
Receives: Behavioral: TEENS+Parent Weight Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index (BMI) Change

    Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month).

    Measured: 4 months to 12 month [follow up phase]

  2. Body Mass Index

    National Health and Nutrition Examination Survey (NHANES) Anthropometry methods were used to measure height and weight to calculate Body Mass Index (BMI). At 0, 2, 4, 8, 12 months, trained staff measured adolescent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

Secondary outcomes (21)
  1. Parent Weight

    Trained staff will measure weight (in light clothing and after a 12 hour fast) to the nearest 0.1kg using digital scale at baseline, 2-, 4-, 8- and 12-months.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  2. Parent Weight Change

    Trained staff will measure weight (in light clothing and after a 12 hour fast) to the nearest 0.1kg using digital scale at baseline and 4-months. Weight change will be calculated from these values.

    Measured: baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase]

  3. Physical Activity

    Accelerometers were worn for 1 week by adolescents and parents for each assessment period (0, 4, 8, and 12 months) to assess adolescent and parent physical activity. Results represent total time (minutes/day) spent in moderate/vigorous activity (MVPA). Data reported is based off the average MVPA minutes per day of valid wear days.

    Measured: Baseline, 4-, 8-, and 12-months

  4. Physical Activity Change

    To assess adolescent and parent physical activity change during the maintenance physical (post-intervention) phase of the program from 4-months to 12-months. Results represent the change in total time (minutes/day) spent in moderate/vigorous activity (MVPA).

    Measured: 4-month to 12-month

  5. Physical Activity Energy Expenditure

    Accelerometers will be worn for 1 week by adolescents and parents for each assessment period (0, 4, 8, and 12 months) to assess adolescent and parent physical activity energy expenditure (EE). Results represent the average daily physical activity energy expenditure (kilocalories/day) estimated via accelerometer. Results are based off EE = (Metabolic Equivalent of Task [MET] value of activity x body weight kg x [minutes of activity/60]) with MET values of 2.5, 4, and 7 utilized for light, moderate, and vigorous activities, respectively.

    Measured: Baseline, 4-, 8-, and 12-months

  6. Physical Activity Energy Expenditure Change

    To assess adolescent and parent physical activity energy expenditure change during the maintenance physical (post-intervention) phase of the program from 4-months to 12-months. Results represent the change in total kilocalories per day from physical activity.

    Measured: 4-month to 12-month

  7. Dietary Intake

    Adolescent and parent participants completed a 3-day food record to track dietary intake for 2 weekdays and 1 weekend day in the week prior to their assessment (0, 4, 8, 12m). Recall data was entered the Nutrition Data System for Research Software (NDSR) by trained staff. Parent and adolescent average total energy intake (kilocalories/day) from the logged days is reported.

    Measured: Baseline, 4-, 8-, and 12-months

  8. Home Food Environment

    The Home Food Inventory (HFI) was used to assess the availability of types of food in the home and calculate an overall obesogenic score. Scores range from 0-60, with high scores indicating a more obesogenic food environment.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  9. Parent Reported Parenting Style

    The Parenting Styles and Dimension Questionnaire (PSDQ) was administered to parents to assess parent self-report of authoritative parenting style. Results reflect the participating parent's perception of their parenting style. Scores range from 1-5 with higher scoring indicating a greater frequency of authoritative parenting behaviors.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  10. Role Modeling

    At 0, 2, 4, 8, 12 months, adolescents will complete the Family Experiences Related to Food Questionnaire (FERFQ) is an 8 or 9-item measure (father and mother version, respectively) that will assess family commentary about weight and shape as well as family modeling of diet and weight concerns. Scores range from 1-5 with higher scores indicating more negative role modeling of dietary behaviors. Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  11. Restrictive Child Feeding Practices

    Parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess restrictive feeding style. Scores range from 1-5 with higher scores indicating a greater degree of restrictive feeding practices.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  12. Overall Weight Control Practices

    Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) which will assess the use of healthy weight control practices (e.g., dietary choices, self-monitoring, and physical activity) at 0, 2, 4, 8, 12 months. A total of 30 items are included in the measure, rated from 0-4. Total scores (ranging from 0-4) are calculated by averaging the scores of the 30 items. Higher scores indicate greater engagement in weight management behaviors.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  13. Self Monitoring Weight Control Practices

    Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) self-monitoring subscale which will assess the use of self-monitoring weight control practices at 0, 2, 4, 8, 12 months. A total of 7 items are included in the measure, rated from 0-4. Scores are calculated by averaging the scores of the 7 items. Higher scores indicate greater engagement in self-monitoring weight management behaviors.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  14. Dietary Choices Weight Control Practices

    Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) dietary choices subscale which will assess the use of dietary choice weight control practices at 0, 2, 4, 8, 12 months. A total of 10 items are included in the measure, rated from 0-4. Scores range from 0 to 4 and are calculated by averaging the scores of the 10 items. Higher scores indicate greater engagement in dietary choice weight management behaviors.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  15. Physical Activity Weight Control Practices

    Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) physical activity subscale which will assess the use of physical activity weight control practices at 0, 2, 4, 8, 12 months. A total of 6 items are included in the measure, rated from 0-4. Scores range from 0 to 4 and are calculated by averaging the scores of the 6 items. Higher scores indicate greater engagement in physical activity weight management behaviors.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  16. Psychological Coping Weight Control Practices

    Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) psychological coping subscale which will assess the use of psychological coping weight control practices at 0, 2, 4, 8, 12 months. A total of 7 items are included in the measure, rated from 0-4. Scores range from 0 to 4 and are calculated by averaging the scores of the 7 items. Higher scores indicate greater engagement in psychological coping weight management behaviors.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  17. Adolescent Reported Responsiveness Parenting Style

    The Authoritative Parenting Index (API) was used to assess adolescent-report of responsiveness parenting style and will be administered at 0, 2, 4, 8, 12 months. Scores range from 9-36 with higher scores indicating greater perceived responsiveness from the parent. Results reflect the adolescent's perception on the parent (mom or dad) participating in the study.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  18. Adolescent Reported Demandingness Parenting Style

    The Authoritative Parenting Index (API) was used to assess adolescent-report of demandingness parenting style and will be administered at 0, 2, 4, 8, 12 months. Scores range from 7-28 with higher scores indicating greater perceived demandingness from the parent. Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  19. Adolescent Reported Authoritative Parenting Style

    The Authoritative Parenting Index (API) was used to assess adolescent-report of authoritative parenting style and was administered at 0, 2, 4, 8, 12 months. Scores range from 16-64 with higher scores indicating the adolescent perceives their parent to have a higher level of authoritative parenting behavior. Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

  20. Home Exercise Environment

    The Exercise Environment Questionnaire (EEQ) assessed the availability of types exercise equipment in the home. Measures will be completed at 0, 4, 8, 12 months. Scores are calculated by summing responses. Scores range from 0-39 with higher scores indicating more exercise equipment in the home.

    Measured: Baseline, 4-, 8-, and 12-months

  21. Monitoring Child Feeding Practices

    Parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess monitoring feeding style. Scores range from 1-5 with higher scores indicating a greater degree of monitoring feeding practices.

    Measured: Baseline, 2-, 4-, 8-, and 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start23 May 2019
  3. Primary completion26 Oct 2024
  4. Study completion26 Oct 2024

Resources

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
Model description
Randomized Control Trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851796
Sponsor's protocol ID
HM20014304
Other IDs
R01HD095910-01A1
Acronym
TEENS+
Status last verified
Nov 2025
First submitted
12 Dec 2018
Last updated
12 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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
  • Bean MK, LaRose JG, Wickham EP 3rd, Raynor HA, Caccavale L, Evans RK, Thornton LM, Farthing S, Mendoza A, Mazzeo SE. The role of parents in behavioral treatment for adolescent obesity: design and rationale for the TEENS+ randomized clinical trial. BMC Public Health. 2023 Aug 4;23(1):1484. doi: 10.1186/s12889-023-16421-0.

    PubMed 37537548

Questions about this trial

What is this clinical trial studying?

A study testing TEENS+Parents as Coaches and TEENS+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 8 inclusion and 34 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 12 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 12 Dec 2025). 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 (BMI) Change (time frame: 4 months to 12 month [follow up phase]). 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?

On the ClinicalTrials.gov record for NCT03851796, which also lists 2 linked publications.

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 12 Dec 2025.

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