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Parent Involvement in Adolescent Obesity Treatment (TEENS+)

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ClinicalTrials.gov Identifier: NCT03851796
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : June 17, 2019
Sponsor:
Collaborators:
University of North Carolina
University of Tennessee
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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


Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: TEENS+Parents as Coaches Behavioral: TEENS+Parent Weight Loss Not Applicable

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 at the study gym. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Assessors and the PI will be blind to treatment group.
Primary Purpose: Treatment
Official Title: The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TEENS+Parents as Coaches

Parents 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.

Behavioral: TEENS+Parents as Coaches
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 Name: Parents as Champions for TEENS (PACT)

Active Comparator: TEENS+Parent Weight Loss

Parents 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.

Behavioral: TEENS+Parent Weight Loss
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 Name: Healthy You!




Primary Outcome Measures :
  1. Adolescent weight loss maintenance [ Time Frame: 8 months [4 month - 12 month follow up] ]
    Primary pre-specified outcome is BMI change (kg/m2; adolescent) during the maintenance phase. At 0, 2, 4, 8, 12 months, trained staff will measure 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. BMI will be calculated (kg/m2); Adolescent BMI Z-scores will be determined using Epi Info software.


Secondary Outcome Measures :
  1. Parent weight loss [ Time Frame: 4 months [0 - 4 month] ]
    trained staff will measure parent 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, at 0, 2, 4, 8, 12 months. Percent weight loss and weight change (kg) from baseline to 4 months is the primary parent weight loss outcome interval.

  2. Physical activity [ Time Frame: 8 months [4 months - 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 objectively. Total time (min/wk) spent in moderate/vigorous activity and mean total daily physical activity energy expenditure (kcal/d) estimated via accelerometer will be examined. The Seven-Day Physical Activity Recall (PAR) will also be administered to participants in person at the same timepoints. This measure asks them to report the approximate number of hours they slept and engaged in moderate, hard and very hard activity for each day of the preceding week.

    Parent and adolescent change in physical activity from 4-12 months during the maintenance period is the primary PA outcome.


  3. Dietary intake [ Time Frame: 8 months [4 months - 12 months] ]
    Adolescent and parent participants will complete 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). Parent and adolescent average total energy intake (kcal/d) from 4-12 months will be the primary dietary outcome.

  4. Parenting Style [ Time Frame: 4 months [0-4 month] ]
    The Authoritative Parenting Index (API) will assess adolescent-report of authoritative parenting style and the Parenting Styles and Dimension Questionnaire (PSDQ) will be administered to parents to assess parent self-report of parenting style. Both measures will be administered at 0, 2, 4, 8, 12 months.

  5. Role Modeling [ Time Frame: 4 months [0-4 month] ]
    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.

  6. Child Feeding [ Time Frame: 4 months [0-4 month] ]
    At 0, 2, 4, 8, 12 months, parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess parent feeding style,

  7. Home Environment [ Time Frame: 4 months [0-4 month] ]
    The Home Food Inventory (HFI) and Exercise Environment Questionnaire (EEQ) will assess availability of types of food or exercise equipment, respectively, in the home. Measures will be completed at 0, 2, 4, 8, 12 months.

  8. Weight control practices [ Time Frame: 12 months [0-4 mo; 4-12 mo] ]
    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.


Other Outcome Measures:
  1. Autonomy Support [ Time Frame: 4 months [0-4 month] ]
    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.

  2. Parent Child Relationship [ Time Frame: 4 months [0-4 month] ]
    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.

  3. Parent Self-efficacy [ Time Frame: 4 months [0-4 month] ]
    The Parent Efficacy for Child Healthy Weight Behavior (PECHWB) will assess parent self-efficacy in promoting healthy weight behaviors in their adolescents. This measure will be completed at 0, 2, 4, 8, 12 months.

  4. Social Support [ Time Frame: 4 months [0-4 month] ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 - 60 years of age
  • 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
  • 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
  • Clinically significant depression
  • Clinically significant eating disorder
  • Change in dose of metformin, oral contraceptives, 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
  • 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
  • Clinically significant depression
  • Clinically significant eating disorder
  • Change in dose of diabetes medications, oral contraceptives, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
  • Admission to a psychiatric hospital within the past year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851796


Contacts
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Contact: Janet D Delorme, MS (804) 527-4756 janet.delorme@vcuhealth.org
Contact: Melanie K Bean, PhD (804) 527-4765 melanie.bean@vcuhealth.org

Locations
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United States, Virginia
Children's Hospital of Richmond at VCU Healthy Lifestyles Center Recruiting
Henrico, Virginia, United States, 23239
Contact: Janet D Delorme, MS    804-527-4756    jdelorm@vcu.edu   
Contact: Melanie K Bean, Ph.D.    (804) 527-4765    mkbean@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
University of North Carolina
University of Tennessee
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Melanie K Bean, PhD Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03851796     History of Changes
Other Study ID Numbers: HM20014304
R01HD095910-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
Pediatric Obesity
Lifestyle Intervention
Family-based Intervention
Motivational Interviewing

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms