- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02334202
Preventing Obesity in Military Communities, Adolescents (POMC-A)
August 1, 2018 updated by: Marian Tanofsky-Kraff, Henry M. Jackson Foundation for the Advancement of Military Medicine
Preventing Obesity in Military Communities, Adolescents (POMC-Adolescents)
This research study is aimed at the prevention of excessive weight gain in female military dependents at high risk for adult obesity.
The purpose of this study is to determine whether reducing Loss of Control (LOC) eating and associated indicators through use of interpersonal psychotherapy (IPT) will be feasible and acceptable to female adolescent dependents who report such behaviors.
Moreover, patterns in the data will be examined to assess whether IPT influences body weight gain trajectories and prevent worsening disordered eating and metabolic functioning among female military dependents at heightened risk for unhealthy weight gain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The increased prevalence of obesity among the children of military personnel has paralleled that observed in the civilian population.
Disordered eating, especially binge or loss of control (LOC) eating, is common among adolescents and is a salient risk factor for obesity and the development of exacerbated disordered eating and depressive symptoms.
The goal of this study is to test the effectiveness of interpersonal psychotherapy (IPT) to slow the trajectory of weight gain in adolescent girls at high-risk for adult obesity by virtue of elevated body mass index (BMI) percentile and LOC eating.
IPT targets the difficult social functioning and stressful events that are associated with LOC and highly relevant to the adolescent youth from military families.
Adolescent military dependents will be randomized to receive either the IPT weight gain prevention program or a health education (HE) control condition, for 12 weekly group sessions.
Adolescents' weight status, eating behaviors, and mood will be assessed at baseline, immediately following the prevention program (12-weeks), and at 1-year follow-up.
At 2-year and 3-year follow-up time points, participants' BMI and physiologic data will be collected via the Military Health System's electronic medical record system.
It is hypothesized that adolescents who receive the IPT group program will show significantly less weight gain (or more weight loss) relative to those randomized to HE at 3-year follow-up.
Additionally, it is hypothesized that adolescents receiving IPT (as compared to HE) will demonstrate improvements on secondary outcomes of interest, including the presence and frequency of classic binge eating episodes, as well as obesity-related physiological measures of health (e.g., fasting insulin).
The overall goal of the study is to prevent excess weight gain and adult obesity, and to prevent worsening disordered eating and metabolic functioning among overweight military dependents at risk for adult obesity and binge eating disorders.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Fort Belvoir, Virginia, United States, 22060
- Fort Belvoir Community Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female
- Age between 12 and 17 years (at the start of the study)
- English-speaking
- Ability to complete study procedures, including ability to participate in a group
- Endorsement of at least one LOC criteria, as assessed by Eating Disorder Examination (EDE) semi structured interview
Exclusion Criteria:
- 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). Non-serious medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
- 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
- Documented or self-reported current pregnancy, current breast-feeding, or recently pregnant girls (within 1 year of delivery). Because pregnancy is a state in which weight gain is expected and appropriate, pregnant individuals would not be suitable for this study. Sexually active females must be using an effective form of birth control. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended. Should a participant in the IPT-WG group become pregnant during the ~12 weeks of the group program, she will be excluded from the group sessions. The study team will closely assist in obtaining an appropriate referral to a community mental healthcare provider, as indicated, and will request a release of information so that they may facilitate a smooth transition for the girl.
- 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. 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 will be permitted. Girls with anorexia or bulimia nervosa will be referred to mental health specialists for further evaluation and treatment. Individuals who need further behavioral health or medical services will be accommodated through their primary care medical home in accordance with normal clinical standard of care. This will be accomplished by direct communication with the patients' primary care physician.
- 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 Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) or any other DSM-IV-TR psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Health Education
The health education group will follow 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 for adolescent military dependents.
|
The health education group will follow 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 with a 90 minute session).
Girls will come in for a 1.5-hour group meeting once a week for 12 weeks (12 times total).
Before beginning the group, girls will meet with group leaders to review each adolescent's family health history.
The curriculum includes focus on various health topics, including avoiding alcohol, drug and tobacco use, nutrition and body image, nonviolent conflict resolution, sun safety, exercise, and domestic violence.
Other Names:
|
Experimental: Interpersonal Psychotherapy-Weight Gain
IPT-WG is designed to decrease excessive weight gain among adolescents who are at risk for adult obesity.
IPT-WG involves developing strategies for dealing with the problems girls struggle with that may lead to increased eating.
The IPT-WG program has been adapted to be appropriate for military dependents.
|
Participants will have 1 individual pre-group session when each participant meets with the group leaders so that they can learn about each girl's significant relationships, set goals for the program, and so each girl can learn about group participation and format.
Participants then will begin IPT-WG which is designed to decrease excessive weight gain among adolescents ages 12-17 years who are at risk for adult obesity.
The IPT-WG program has been adapted to be appropriate for military dependents.
The IPT-WG group meets for 12 consecutive, weekly group meetings and involves developing strategies for dealing with the problems girls struggle with that may lead to increased eating.
At the 6th week of the group, the group leaders meet with each participant to review their progress and goals.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index metrics
Time Frame: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
|
Participants will be weighed using professional grade equipment and trained personnel.
|
Baseline, Change from baseline at post-intervention, 1-year, and 2-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social and emotional functioning
Time Frame: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
|
Participant composite scores on measures of disordered eating, depressive and anxiety symptoms, as measured by an extensive battery of standardized assessments.
|
Baseline, Change from baseline at post-intervention, 1-year, and 2-year
|
Blood-based metabolic markers
Time Frame: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
|
Blood drawn for measurement of triglycerides, HDL cholesterol, glucose, and other indicators of obesity risk -e.g.
hormones thought to affect appetite and weight.
|
Baseline, Change from baseline at post-intervention, 1-year, and 2-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marian Tanofsky-Kraff, Ph.D., Uniformed Services University of the Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
December 23, 2014
First Submitted That Met QC Criteria
January 7, 2015
First Posted (Estimate)
January 8, 2015
Study Record Updates
Last Update Posted (Actual)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F172NC-S2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Health Education
-
Federal University of PelotasRecruiting
-
University of PretoriaUnknown
-
Universiti Sains MalaysiaNot yet recruitingKnowledge, Attitudes, Practice | Early Childhood Caries
-
Junyan ZhaoActive, not recruitingTumor Chemotherapy PatientsChina
-
Tianjin HospitalCompletedLumbar Disc HerniationChina
-
Federal University of PelotasRecruitingBreast Cancer FemaleBrazil
-
Taipei Medical UniversityActive, not recruiting
-
Chang Gung University of Science and TechnologyEnrolling by invitation
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompletedEarly Detection of CancerTurkey
-
University of WashingtonNational Institute on Aging (NIA)RecruitingOsteo Arthritis KneeUnited States