Recruiting

Observational Study

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT02671292

Conditions

Obesity

Overweight

Binge Eating

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

Interpersonal Psychotherapy

Health Education

Study Details

Brief summary:

To determine whether reducing loss of control eating (LOC) with Interpersonal Psychotherapy-Weight Gain (IPT-WG) will be effective for adolescent military-dependents who report such behavior. The investigators will examine whether IPT-WG influences body weight gain trajectories and prevents worsening disordered eating, psychosocial problems, and metabolic functioning among military dependents at heightened risk for adult obesity and disordered eating. This study will provide key efficacy data for a new promising obesity prevention program for youth from military families.

Conditions

Obesity

Overweight

Binge Eating

Study ID

NCT02671292

Start date

Jul, 2015

Status verified date

Feb, 2019

Completion date

May, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Adolescent Inclusion Criteria:

1. Age between 12 and 17 years (at the start of the study)
2. BMI at or above the 85th percentile for age and sex
3. English-speaking
4. Ability to complete study procedures, including the ability to participate in a group
5. > 1 episode of LOC eating during the 3 months prior to assessment
6. Must have a parent(s) enrolled in TRICARE at the time of study initiation

Parent Inclusion Criteria:

1.The consenting parent or caregiver must be able to comprehend English.

Adolescent Exclusion Criteria:

1. Presence of a chronic major medical illness: renal, hepatic, gastrointestinal, endocrinologic (e.g., Cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication).
2. Presence of a documented, obesity-related medical complication that would require a more aggressive weight loss intervention approach: type 2 diabetes, hyperlipidemia, hypertension, fasting hyperglycemia, or nonalcoholic steatohepatitis.
3. Self-reported current pregnancy, current breast-feeding, or recently pregnant girls (within 1 year of delivery).
4. Current, regular use of prescription medications that affect appetite, mood, or body weight: currently prescribed SSRI's, neuroleptics, tricyclics, stimulants, or any other medication known to affect appetite, mood, or body weight. For girls, oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting the prevention groups. Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.
5. Current involvement in psychotherapy or a structured weight loss program.
6. Weight loss during the past two months for any reason exceeding 3% of body weight.
7. Current anorexia nervosa or bulimia nervosa as determined by documented medical history or if uncovered during K-SADS semi-structured interview. Current binge eating disorder (BED) will be permitted, although adolescents will be informed that they have an eating disorder and have the option to participate in the study or seek outside treatment (and not participate in the study).
8. Individuals who have major depressive disorder, psychoses, current substance or alcohol abuse, conduct disorder, as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) semi-structured interview and as defined by criteria outlined in the DSM-5, or any other DSM psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.

Parent Exclusion Criteria:

1. None

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Interpersonal Psychotherapy (IPT-WG)

IPT-WG targets the difficult social functioning and stressful events that are associated with loss of control eating and that are highly relevant to the adolescent children of military personnel.

active comparator: Health Education (HE)

HE improves knowledge on various health topics including, alcohol, drug and tobacco use, depression and suicide, nutrition and body image, nonviolent conflict resolution, sun safety, exercise, and domestic violence.

Interventions

Interpersonal Psychotherapy

IPT-WG involves one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions. The IPT-WG group sessions follow 3 phases (initial, middle, and termination) and use the interpersonal inventory to identify interpersonal problems that might be contributing to or exacerbated by LOC eating. A framework of common problem areas is used to teach interpersonal problem-solving and communication skills and educate youth about risk factors for excessive weight gain and warning signs such as eating in response to negative affect as opposed to hunger, or feeling a sense of LOC while eating.

Health Education

The HE group is based upon the "HEY-Durham" health program designed by researchers at Duke University. This program, designed to be delivered to youth attending community high schools, was adapted to a 12-week program (each session is 90 minutes). Additionally, individuals will attend a pre-group individual meeting with the group leaders to review family health history.The curriculum includes focus on various health topics, including alcohol, drug and tobacco use, depression and suicide, nutrition and body image, nonviolent conflict resolution, sun safety, exercise, and domestic violence. Session content will be largely identical for boys and girls, with the exception of gender-specific videos and articles (e.g., on body image), which will be tailored for each sex.

Primary outcome measure

  • Participant Weight [ Time Frame: Change in weight from baseline to 3 years post-treatment ]

Central Contacts and Locations

Central contacts

Locations

Uniformed Services University of the Health Sciences

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Fort Belvoir Community Hospital

Recruiting

Fort Belvoir, Virginia, United States, 22060

Contacts

Principal Investigator:

David Klein, MD

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Feb 26, 2019

Last verified

Feb, 2019

Keywords

  • Loss of Control Eating
  • Binge Eating
  • Obesity
  • Prevention
  • Interpersonal Psychotherapy
  • Adolescent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2019-02-26.