Obesity Clinical Trial
— POMC-AOfficial title:
Preventing Obesity in Military Communities, Adolescents (POMC-Adolescents)
NCT number | NCT02334202 |
Other study ID # | F172NC-S2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2011 |
Est. completion date | August 2018 |
Verified date | August 2018 |
Source | Henry M. Jackson Foundation for the Advancement of Military Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years to 17 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Fort Belvoir Community Hospital | Fort Belvoir | Virginia |
Lead Sponsor | Collaborator |
---|---|
Henry M. Jackson Foundation for the Advancement of Military Medicine | Fort Belvoir Community Hospital |
United States,
Tanofsky-Kraff M, Sbrocco T, Theim KR, Cohen LA, Mackey ER, Stice E, Henderson JL, McCreight SJ, Bryant EJ, Stephens MB. Obesity and the US military family. Obesity (Silver Spring). 2013 Nov;21(11):2205-20. doi: 10.1002/oby.20566. Epub 2013 Sep 5. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body mass index metrics | Participants will be weighed using professional grade equipment and trained personnel. | Baseline, Change from baseline at post-intervention, 1-year, and 2-year | |
Secondary | Social and emotional functioning | 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 | |
Secondary | Blood-based metabolic markers | 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 |
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