Preventing Obesity in Military Communities-Adolescents
POMC-A
2 other identifiers
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jul 2015
Longer than P75 for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFebruary 26, 2019
February 1, 2019
5.8 years
July 9, 2015
February 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant Weight
Weight will be measured
Change in weight from baseline to 3 years post-treatment
Secondary Outcomes (9)
Presence of binge eating
Change in presence of binge eating from baseline to 1 year post-treatment
Waist Circumference
Change in waist circumference from baseline to 3 years post-treatment
Blood Pressure
Change in blood pressure from baseline to 3 years post-treatment
Triglycerides
Change in triglycerides from baseline to 3 years post-treatment
HDL Cholesterol
Change in HDL cholesterol from baseline to 3 years post-treatment
- +4 more secondary outcomes
Study Arms (2)
Interpersonal Psychotherapy (IPT-WG)
EXPERIMENTALIPT-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.
Health Education (HE)
ACTIVE COMPARATORHE 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
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.
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.
Eligibility Criteria
You may qualify if:
- Age between 12 and 17 years (at the start of the study)
- BMI at or above the 85th percentile for age and sex
- English-speaking
- Ability to complete study procedures, including the ability to participate in a group
- \> 1 episode of LOC eating during the 3 months prior to assessment
- Must have a parent(s) enrolled in TRICARE at the time of study initiation
- The consenting parent or caregiver must be able to comprehend English.
You may not qualify if:
- 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).
- 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.
- Self-reported current pregnancy, current breast-feeding, or recently pregnant girls (within 1 year of delivery).
- 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.
- Current involvement in psychotherapy or a structured weight loss program.
- Weight loss during the past two months for any reason exceeding 3% of body weight.
- 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).
- 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.
- \. None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060, United States
Related Publications (1)
Solomon S, Shank LM, Lavender JM, Neyland MKH, Gallager-Teske J, Markos B, Haynes H, Repke H, Rice AJ, Sbrocco T, Wilfley DE, Schvey NA, Jorgensen S, Ford B, Ford CB, Haigney M, Klein DA, Quinlan J, Tanofsky-Kraff M. The Relationship Between Anxiety, Coping, and Disordered-Eating Attitudes in Adolescent Military-Dependents at High-Risk for Excess Weight Gain. Mil Psychol. 2023;35(2):95-106. doi: 10.1080/08995605.2022.2083448. Epub 2022 Jun 21.
PMID: 36968637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marian Tanofsky-Kraff, Ph.D.
Uniformed Services University of the Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2015
First Posted
February 2, 2016
Study Start
July 1, 2015
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
February 26, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share