Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DK104115 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fort Belvoir Community Hospital | FED |
| Walter Reed National Military Medical Center | FED |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpersonal Psychotherapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Weight | Weight will be measured | Change in weight from baseline to 3 years post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Adolescent Inclusion Criteria:
Parent Inclusion Criteria:
1.The consenting parent or caregiver must be able to comprehend English.
Adolescent Exclusion Criteria:
Parent Exclusion Criteria:
1. None
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abigail Pine, B.A. | Contact | 301-295-1598 | abigail.pine.ctr@usuhs.edu | |
| Mary Quattlebaum, B.A. | Contact | 301-295-0864 | mary.quattlebaum.ctr@usuhs.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marian Tanofsky-Kraff, Ph.D. | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniformed Services University of the Health Sciences | Recruiting | Bethesda | Maryland | 20814 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41797473 | Derived | 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. | |
| 36968637 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2018 | Feb 6, 2019 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
| ID | Term |
|---|---|
| D000079062 | Interpersonal Psychotherapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Health Education | Other | 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. |
|
| 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. | Change in waist circumference from baseline to 3 years post-treatment |
| Blood Pressure | Blood pressure will be measured using an automatic blood pressure cuff. | 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. | 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. | 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. | 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. | 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. | Change in hemoglobin A1c from baseline to 3 years post-treatment |
| BMI Percentile | Height and weight will be measured and BMI percentile calculated | Change in BMI percentile from baseline to 3 years post-treatment |
| Fort Belvoir Community Hospital | Recruiting | Fort Belvoir | Virginia | 22060 | United States |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |