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Preventing Obesity in Military Communities-Adolescents (POMC-A)

Primary Purpose

Obesity, Overweight, Binge Eating

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
Health Education
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Loss of Control Eating, Binge Eating, Obesity, Prevention, Interpersonal Psychotherapy, Adolescent

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Adolescent 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

Parent Inclusion Criteria:

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

Adolescent 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.

Parent Exclusion Criteria:

1. None

Sites / Locations

  • Uniformed Services University of the Health SciencesRecruiting
  • Fort Belvoir Community HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpersonal Psychotherapy (IPT-WG)

Health Education (HE)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Participant Weight
Weight will be measured

Secondary Outcome Measures

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).
Waist Circumference
Waist circumference will be measured using a flexible measuring tape.
Blood Pressure
Blood pressure will be measured using an automatic blood pressure cuff.
Triglycerides
Blood will be drawn to collect a sample for the measurement of triglycerides.
HDL Cholesterol
Blood will be drawn to collect a sample for the measurement of HDL.
Insulin Function
Blood will be drawn to collect a sample for the measurement of insulin.
Glucose
Blood will be drawn to collect a sample for the measurement of glucose.
Hemoglobin A1c
Blood will be drawn to collect a sample for the measurement of hemoglobin A1c.
BMI Percentile
Height and weight will be measured and BMI percentile calculated

Full Information

First Posted
July 9, 2015
Last Updated
February 23, 2019
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Fort Belvoir Community Hospital, Walter Reed National Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02671292
Brief Title
Preventing Obesity in Military Communities-Adolescents
Acronym
POMC-A
Official Title
Preventing Obesity in Military Communities-Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborators
Fort Belvoir Community Hospital, Walter Reed National Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Binge Eating
Keywords
Loss of Control Eating, Binge Eating, Obesity, Prevention, Interpersonal Psychotherapy, Adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Psychotherapy (IPT-WG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Education (HE)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
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
Other
Intervention Name(s)
Health Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant Weight
Description
Weight will be measured
Time Frame
Change in weight from baseline to 3 years post-treatment
Secondary Outcome Measure Information:
Title
Presence of binge eating
Description
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).
Time Frame
Change in presence of binge eating from baseline to 1 year post-treatment
Title
Waist Circumference
Description
Waist circumference will be measured using a flexible measuring tape.
Time Frame
Change in waist circumference from baseline to 3 years post-treatment
Title
Blood Pressure
Description
Blood pressure will be measured using an automatic blood pressure cuff.
Time Frame
Change in blood pressure from baseline to 3 years post-treatment
Title
Triglycerides
Description
Blood will be drawn to collect a sample for the measurement of triglycerides.
Time Frame
Change in triglycerides from baseline to 3 years post-treatment
Title
HDL Cholesterol
Description
Blood will be drawn to collect a sample for the measurement of HDL.
Time Frame
Change in HDL cholesterol from baseline to 3 years post-treatment
Title
Insulin Function
Description
Blood will be drawn to collect a sample for the measurement of insulin.
Time Frame
Change in insulin sensitivity from baseline to 3 years post-treatment
Title
Glucose
Description
Blood will be drawn to collect a sample for the measurement of glucose.
Time Frame
Change in glucose from baseline to 3 years post-treatment
Title
Hemoglobin A1c
Description
Blood will be drawn to collect a sample for the measurement of hemoglobin A1c.
Time Frame
Change in hemoglobin A1c from baseline to 3 years post-treatment
Title
BMI Percentile
Description
Height and weight will be measured and BMI percentile calculated
Time Frame
Change in BMI percentile from baseline to 3 years post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 1. None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Pine, B.A.
Phone
301-295-1598
Email
abigail.pine.ctr@usuhs.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Quattlebaum, B.A.
Phone
301-295-0864
Email
mary.quattlebaum.ctr@usuhs.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Tanofsky-Kraff, Ph.D.
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of the Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Pine, B.A.
Phone
301-295-1598
Email
abigail.pine.ctr@usuhs.edu
First Name & Middle Initial & Last Name & Degree
Mary Quattlebaum, B.A.
Phone
301-295-0864
Email
mary.quattlebaum.ctr@usuhs.edu
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Pine, B.A.
Phone
301-295-1598
Email
abigail.pine.ctr@usuhs.edu
First Name & Middle Initial & Last Name & Degree
Mary Quattlebaum, B.A.
Phone
301-295-0864
Email
mary.quattlebaum.ctr@usuhs.edu
First Name & Middle Initial & Last Name & Degree
David Klein, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing Obesity in Military Communities-Adolescents

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