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Completed

NCT Number: NCT03851796

Parent Involvement in Adolescent Obesity Treatment

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

Completed

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Key information

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
  • 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

Treatment and study plan

TEENS+Parents as Coaches

Behavioral

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

Other names: Parents as Champions for TEENS (PACT)

TEENS+Parent Weight Loss

Behavioral

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.

Other names: Healthy You!

Primary outcomes

  1. Body Mass Index (BMI) Change

    Time frame: 4 months to 12 month [follow up phase]

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

  2. Body Mass Index

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

Secondary outcomes

  1. Parent Weight

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  2. Parent Weight Change

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

    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.

  3. Physical Activity

    Time frame: Baseline, 4-, 8-, and 12-months

    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.

  4. Physical Activity Change

    Time frame: 4-month to 12-month

    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).

  5. Physical Activity Energy Expenditure

    Time frame: Baseline, 4-, 8-, and 12-months

    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.

  6. Physical Activity Energy Expenditure Change

    Time frame: 4-month to 12-month

    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.

  7. Dietary Intake

    Time frame: Baseline, 4-, 8-, and 12-months

    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.

  8. Home Food Environment

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  9. Parent Reported Parenting Style

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  10. Role Modeling

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  11. Restrictive Child Feeding Practices

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  12. Overall Weight Control Practices

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  13. Self Monitoring Weight Control Practices

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  14. Dietary Choices Weight Control Practices

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  15. Physical Activity Weight Control Practices

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  16. Psychological Coping Weight Control Practices

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  17. Adolescent Reported Responsiveness Parenting Style

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  18. Adolescent Reported Demandingness Parenting Style

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  19. Adolescent Reported Authoritative Parenting Style

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

  20. Home Exercise Environment

    Time frame: Baseline, 4-, 8-, and 12-months

    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.

  21. Monitoring Child Feeding Practices

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    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.

Other outcomes

  1. Autonomy Support

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    At 0, 2, 4, 8, 12 months, adolescents will complete the Perceived Parental Autonomy Support Scale (P-PASS) to assess adolescent perception of 1) autonomy-supportive parenting behaviors and 2) controlling parenting behaviors. Items are rated on a 7-point Likert scale from 1-7. The average score across all items is calculated. Higher scores indicate a greater perception of parental autonomy support. Lower scores indicate less support and more controlling behaviors.

  2. Parent Child Relationship

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    The Conflict Behavior Questionnaire (CBQ; Parent and Adolescent Versions) will assess parent and adolescent report of parent-child relational factors at 0, 2, 4, 8, 12 mo. Scores range from 0-20. Higher score indicate more conflict between parent and child and lower scores indicating less conflict. Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.

  3. Parent Self-efficacy

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    The Parent Efficacy for Child Healthy Weight Behavior (PECHWB) will assess parent self-efficacy in promoting healthy weight behaviors in their adolescents. Scores range from 0-100 with higher scores indicating higher self-efficacy.

  4. Social Support

    Time frame: Baseline, 2-, 4-, 8-, and 12-months

    At 0, 2, 4, 8, 12 months, adolescents will complete family and friend social support scales from the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE+) questionnaires to assess adolescent report of family and friend social support across 3 domains: 1) fruit and vegetable intake, 2) fat intake, and 3) physical activity. Scores range from 1-5 with higher indicating greater social support.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of North Carolina
  • University of Tennessee

Registry information

Official study title

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

Acronym: TEENS+

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2019
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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