Preventing Obesity in Military Communities-Adolescents

NCT ID: NCT02671292

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2021-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Interpersonal Psychotherapy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

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

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.

1. None

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fort Belvoir Community Hospital

FED

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marian Tanofsky-Kraff, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Uniformed Services University of the Health Sciences

Bethesda, Maryland, United States

Site Status: RECRUITING

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Abigail Pine, B.A.

Role: CONTACT

abigail.pine.ctr@usuhs.edu

301-295-1598

Mary Quattlebaum, B.A.

Role: CONTACT

mary.quattlebaum.ctr@usuhs.edu

301-295-0864

Facility Contacts

Abigail Pine, B.A.

Role: primary

abigail.pine.ctr@usuhs.edu

301-295-1598

Mary Quattlebaum, B.A.

Role: backup

mary.quattlebaum.ctr@usuhs.edu

301-295-0864

Abigail Pine, B.A.

Role: primary

abigail.pine.ctr@usuhs.edu

301-295-1598

Mary Quattlebaum, B.A.

Role: backup

mary.quattlebaum.ctr@usuhs.edu

301-295-0864

References

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.

Reference Type: DERIVED

PMID: 36968637 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK104115

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MPS-72-3248

Identifier Type: -

Identifier Source: org_study_id