ObesityPOMC-ANCT02671292
Preventing Obesity in Military Communities-Adolescents
A study testing Interpersonal Psychotherapy and Health Education in people with Obesity and Overweight, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Binge Eating
- What is being tested?
- Interpersonal Psychotherapy and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Adolescent Inclusion Criteria:
- 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
Parent Inclusion Criteria:
1.The consenting parent or caregiver must be able to comprehend English.
Adolescent 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).
- 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.
Parent Exclusion Criteria:
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
Abigail Pine, B.A., 301-295-1598, abigail.pine.ctr@usuhs.edu
Mary Quattlebaum, B.A., 301-295-0864, mary.quattlebaum.ctr@usuhs.edu
- Recruiting
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
Abigail Pine, B.A., 301-295-1598, abigail.pine.ctr@usuhs.edu
Mary Quattlebaum, B.A., 301-295-0864, mary.quattlebaum.ctr@usuhs.edu
About this study
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.
Read the detailed description
The prevalence of overweight among military personnel and their dependents is at a rate similar to that of the civilian population. Nearly 30% of adolescent dependents are overweight, including approximately 15-17% who are obese, placing them at high risk for impairments in metabolic functioning, type 2 diabetes, and adult obesity. Youth who are overweight (body mass index, kg/m2, BMI ≥ 85th percentile) are at high risk for excess weight gain as they grow. Since effective weight loss and maintenance treatments are rare, prevention may be the most important approach to reducing the high prevalence of obesity. To date, most pediatric obesity prevention programs have been met with limited success. To address those at greatest risk for obesity, more targeted approaches may be required. There is a need to reduce prospectively identified risk factors in order to prevent excess weight gain in youth at high risk for adult obesity. The most common disordered eating behavior among overweight adolescents is loss of control (LOC) eating, during which the feeling of being unable to stop eating is experienced. LOC eating predisposes youth to gain excessive weight and fat. Thus, LOC eating is likely to be an important contributor to obesity in susceptible individuals. Decreasing LOC in adolescents may prevent excess weight gain. Investigators at the Uniformed Services University of the Health Sciences (USUHS) is in partnership with Ft. Belvoir Community Hospital (FBCH) and Walter Reed National Military Medical Center (WRNMMC) to test the effectiveness of IPT-WG to slow the trajectory of weight gain in overweight adolescent boys and girls who report LOC and prevent worsening disordered eating and metabolic functioning. The unique stress burdening the children of military personnel while the country is at war suggests that obesity prevention programs targeting interpersonal stress and promoting positive social functioning may be especially timely in this population. It is hypothesized that IPT-WG will decrease LOC eating and related eating behaviors and, in turn, prevent excess weight gain and the development of exacerbated disordered eating in adolescent children of military personnel. Secondary to the prevention of excess weight gain, youth will experience improvements in metabolic functioning.
- Conditions
- Obesity, Overweight, Binge Eating
- Being tested
- Interpersonal Psychotherapy, Health Education
- Keywords
- Loss of Control Eating, Binge Eating, Obesity, Prevention, Interpersonal Psychotherapy, Adolescent
- Medical subject headings
- Obesity, Overweight, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal PsychotherapyBehavioural
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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy (IPT-WG) | Experimental | 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. Receives: Behavioral: Interpersonal Psychotherapy |
| Health Education (HE) | Active comparator | 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. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Weight
Weight will be measured
Measured: Change in weight from baseline to 3 years post-treatment
Secondary outcomes (9)
Presence of binge eating
The Eating Disorder Examination (EDE) will be administered to assess for the presence of binge eating. The EDE identifies three types of eating episodes: objective binge eating (overeating with LOC), subjective binge eating (LOC without objective overeating as assessed by the interviewer, but viewed as excessive by the interviewee), and objective overeating (overeating without LOC), as well as the range of compensatory behaviors described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Measured: Change in presence of binge eating from baseline to 1 year post-treatment
Waist Circumference
Waist circumference will be measured using a flexible measuring tape.
Measured: Change in waist circumference from baseline to 3 years post-treatment
Blood Pressure
Blood pressure will be measured using an automatic blood pressure cuff.
Measured: Change in blood pressure from baseline to 3 years post-treatment
Triglycerides
Blood will be drawn to collect a sample for the measurement of triglycerides.
Measured: Change in triglycerides from baseline to 3 years post-treatment
HDL Cholesterol
Blood will be drawn to collect a sample for the measurement of HDL.
Measured: Change in HDL cholesterol from baseline to 3 years post-treatment
Insulin Function
Blood will be drawn to collect a sample for the measurement of insulin.
Measured: Change in insulin sensitivity from baseline to 3 years post-treatment
Glucose
Blood will be drawn to collect a sample for the measurement of glucose.
Measured: Change in glucose from baseline to 3 years post-treatment
Hemoglobin A1c
Blood will be drawn to collect a sample for the measurement of hemoglobin A1c.
Measured: Change in hemoglobin A1c from baseline to 3 years post-treatment
BMI Percentile
Height and weight will be measured and BMI percentile calculated
Measured: Change in BMI percentile from baseline to 3 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fort Belvoir Community Hospital, Walter Reed National Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Marian Tanofsky-Kraff, Ph.D., Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671292
- Sponsor's protocol ID
- MPS-72-3248
- Other IDs
- R01DK104115
- Acronym
- POMC-A
- Status last verified
- Feb 2019
- First submitted
- 9 Jul 2015
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ranzenhofer LM, Shank LM, Thompson K, Schvey N, Wilfley DE, Young JF, Burke NL, Olsen CH, Lavender JM, Schrag R, Jorgensen S, Quinlan J, Klein DA, Haigney M, Yanovski JA, Sbrocco T, Tanofsky-Kraff M. Prevention of Excess Weight Gain Among Adolescent Military-Dependents at High Risk for Obesity. Obesity (Silver Spring). 2026 Jun;34 Suppl 1:54-64. doi: 10.1002/oby.70165. Epub 2026 Mar 9.
PubMed 41797473Solomon 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.
PubMed 36968637
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Obesity in Military Communities-Adolescents
- ClinicalTrials.gov ID
- NCT02671292
- Acronym / sponsor ID
- POMC-A / MPS-72-3248
- Conditions
- Obesity, Overweight, Binge Eating
- Keywords
- Loss of Control Eating, Binge Eating, Obesity, Prevention, Interpersonal Psychotherapy, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Fort Belvoir Community Hospital, Walter Reed National Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2015
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The prevalence of overweight among military personnel and their dependents is at a rate similar to that of the civilian population. Nearly 30% of adolescent dependents are overweight, including approximately 15-17% who are obese, placing them at high risk for impairments in metabolic functioning, type 2 diabetes, and adult obesity. Youth who are overweight (body mass index, kg/m2, BMI ≥ 85th percentile) are at high risk for excess weight gain as they grow. Since effective weight loss and maintenance treatments are rare, prevention may be the most important approach to reducing the high prevalence of obesity. To date, most pediatric obesity prevention programs have been met with limited success. To address those at greatest risk for obesity, more targeted approaches may be required. There is a need to reduce prospectively identified risk factors in order to prevent excess weight gain in youth at high risk for adult obesity. The most common disordered eating behavior among overweight adolescents is loss of control (LOC) eating, during which the feeling of being unable to stop eating is experienced. LOC eating predisposes youth to gain excessive weight and fat. Thus, LOC eating is likely to be an important contributor to obesity in susceptible individuals. Decreasing LOC in adolescents may prevent excess weight gain. Investigators at the Uniformed Services University of the Health Sciences (USUHS) is in partnership with Ft. Belvoir Community Hospital (FBCH) and Walter Reed National Military Medical Center (WRNMMC) to test the effectiveness of IPT-WG to slow the trajectory of weight gain in overweight adolescent boys and girls who report LOC and prevent worsening disordered eating and metabolic functioning. The unique stress burdening the children of military personnel while the country is at war suggests that obesity prevention programs targeting interpersonal stress and promoting positive social functioning may be especially timely in this population. It is hypothesized that IPT-WG will decrease LOC eating and related eating behaviors and, in turn, prevent excess weight gain and the development of exacerbated disordered eating in adolescent children of military personnel. Secondary to the prevention of excess weight gain, youth will experience improvements in metabolic functioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy (IPT-WG) | Experimental | Behavioral: Interpersonal PsychotherapyIPT-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 comparator | Other: Health EducationHE 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal PsychotherapyIPT-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. | Behavioural | Interpersonal Psychotherapy (IPT-WG) |
| Health EducationThe 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. | Other | Health Education (HE) |
Primary outcome
Participant Weight
Time frame: Change in weight from baseline to 3 years post-treatment
Weight will be measured
9 secondary outcomes
Presence of binge eating
Time frame: Change in presence of binge eating from baseline to 1 year post-treatment
Waist Circumference
Time frame: Change in waist circumference from baseline to 3 years post-treatment
Blood Pressure
Time frame: Change in blood pressure from baseline to 3 years post-treatment
Triglycerides
Time frame: Change in triglycerides from baseline to 3 years post-treatment
HDL Cholesterol
Time frame: Change in HDL cholesterol from baseline to 3 years post-treatment
Insulin Function
Time frame: Change in insulin sensitivity from baseline to 3 years post-treatment
Glucose
Time frame: Change in glucose from baseline to 3 years post-treatment
Hemoglobin A1c
Time frame: Change in hemoglobin A1c from baseline to 3 years post-treatment
BMI Percentile
Time frame: Change in BMI percentile from baseline to 3 years post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Derived from this study: PubMed 41797473Ranzenhofer LM, Shank LM, Thompson K, Schvey N, Wilfley DE, Young JF, Burke NL, Olsen CH, Lavender JM, Schrag R, Jorgensen S, Quinlan J, Klein DA, Haigney M, Yanovski JA, Sbrocco T, Tanofsky-Kraff M. Prevention of Excess Weight Gain Among Adolescent Military-Dependents at High Risk for Obesity. Obesity (Silver Spring). 2026 Jun;34 Suppl 1:54-64. doi: 10.1002/oby.70165. Epub 2026 Mar 9.
- Derived from this study: PubMed 36968637Solomon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marian Tanofsky-Kraff, Ph.D. principal investigator
Uniformed Services University of the Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy and Health Education in people with Obesity and Overweight, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abigail Pine, B.A. (301-295-1598, abigail.pine.ctr@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Weight (time frame: Change in weight from baseline to 3 years post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02671292, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.