ObesityPOMC-ANCT02334202
Preventing Obesity in Military Communities, Adolescents
A study testing Interpersonal Psychotherapy-Weight Gain and Health Education in people with Obesity and Weight Gain, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Obesity, Weight Gain, Disordered Eating
- What is being tested?
- Interpersonal Psychotherapy-Weight Gain and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2018
- 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
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060
About this study
Official title: Preventing Obesity in Military Communities, Adolescents (POMC-Adolescents)
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.
Read the detailed description
The increased prevalence of obesity among the children of military personnel has paralleled that observed in the civilian population. Disordered eating, especially binge or loss of control (LOC) eating, is common among adolescents and is a salient risk factor for obesity and the development of exacerbated disordered eating and depressive symptoms. The goal of this study is to test the effectiveness of interpersonal psychotherapy (IPT) to slow the trajectory of weight gain in adolescent girls at high-risk for adult obesity by virtue of elevated body mass index (BMI) percentile and LOC eating. IPT targets the difficult social functioning and stressful events that are associated with LOC and highly relevant to the adolescent youth from military families. Adolescent military dependents will be randomized to receive either the IPT weight gain prevention program or a health education (HE) control condition, for 12 weekly group sessions. Adolescents' weight status, eating behaviors, and mood will be assessed at baseline, immediately following the prevention program (12-weeks), and at 1-year follow-up. At 2-year and 3-year follow-up time points, participants' BMI and physiologic data will be collected via the Military Health System's electronic medical record system. It is hypothesized that adolescents who receive the IPT group program will show significantly less weight gain (or more weight loss) relative to those randomized to HE at 3-year follow-up. Additionally, it is hypothesized that adolescents receiving IPT (as compared to HE) will demonstrate improvements on secondary outcomes of interest, including the presence and frequency of classic binge eating episodes, as well as obesity-related physiological measures of health (e.g., fasting insulin). The overall goal of the study is to prevent excess weight gain and adult obesity, and to prevent worsening disordered eating and metabolic functioning among overweight military dependents at risk for adult obesity and binge eating disorders.
- Conditions
- Obesity, Weight Gain, Disordered Eating, Eating Disorder
- Being tested
- Interpersonal Psychotherapy-Weight Gain, Health Education
- Keywords
- Adolescent, Obesity/Psychology, Loss of Control Eating, Child, Female, Follow-Up Studies, Health Behavior, Health Education, Humans, Intervention Studies, Prospective Studies, Psychotherapy, Risk Factors, Weight Loss, Weight Gain, Military
- Medical subject headings
- Obesity, Weight Gain, Feeding and Eating Disorders, Health Behavior, Health Education, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy-Weight GainBehavioural
Also called IPT-WG
Participants will have 1 individual pre-group session when each participant meets with the group leaders so that they can learn about each girl's significant relationships, set goals for the program, and so each girl can learn about group participation and format. Participants then will begin IPT-WG which is designed to decrease excessive weight gain among adolescents ages 12-17 years who are at risk for adult obesity. The IPT-WG program has been adapted to be appropriate for military dependents. The IPT-WG group meets for 12 consecutive, weekly group meetings and involves developing strategies for dealing with the problems girls struggle with that may lead to increased eating. At the 6th week of the group, the group leaders meet with each participant to review their progress and goals.
Health EducationOther
Also called HEY-Durham (edited for POMC-A)
The health education group will follow 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 with a 90 minute session). Girls will come in for a 1.5-hour group meeting once a week for 12 weeks (12 times total). Before beginning the group, girls will meet with group leaders to review each adolescent's family health history. The curriculum includes focus on various health topics, including avoiding alcohol, drug and tobacco use, nutrition and body image, nonviolent conflict resolution, sun safety, exercise, and domestic violence.
| Study group | Role | What they receive |
|---|---|---|
| Health Education | Active comparator | The health education group will follow 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 for adolescent military dependents. Receives: Other: Health Education |
| Interpersonal Psychotherapy-Weight Gain | Experimental | IPT-WG is designed to decrease excessive weight gain among adolescents who are at risk for adult obesity. IPT-WG involves developing strategies for dealing with the problems girls struggle with that may lead to increased eating. The IPT-WG program has been adapted to be appropriate for military dependents. Receives: Behavioral: Interpersonal Psychotherapy-Weight Gain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index metrics
Participants will be weighed using professional grade equipment and trained personnel.
Measured: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
Secondary outcomes (2)
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.
Measured: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
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.
Measured: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startNov 2011
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 48 participants (actual)
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
- Responsible party
- Principal investigator, Marian Tanofsky-Kraff, Uniformed Services University of the Health Sciences
- Investigators
- Marian Tanofsky-Kraff, Ph.D., Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334202
- Sponsor's protocol ID
- F172NC-S2
- Acronym
- POMC-A
- Status last verified
- Aug 2018
- First submitted
- 23 Dec 2014
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23836452
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Obesity in Military Communities, Adolescents (POMC-Adolescents)
- ClinicalTrials.gov ID
- NCT02334202
- Acronym / sponsor ID
- POMC-A / F172NC-S2
- Conditions
- Obesity, Weight Gain, Disordered Eating, Eating Disorder
- Keywords
- Adolescent, Obesity/Psychology, Loss of Control Eating, Child, Female, Follow-Up Studies, Health Behavior, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Fort Belvoir Community Hospital
- Study start
- Nov 2011
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Jan 2015 (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.
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.
Detailed description
The increased prevalence of obesity among the children of military personnel has paralleled that observed in the civilian population. Disordered eating, especially binge or loss of control (LOC) eating, is common among adolescents and is a salient risk factor for obesity and the development of exacerbated disordered eating and depressive symptoms. The goal of this study is to test the effectiveness of interpersonal psychotherapy (IPT) to slow the trajectory of weight gain in adolescent girls at high-risk for adult obesity by virtue of elevated body mass index (BMI) percentile and LOC eating. IPT targets the difficult social functioning and stressful events that are associated with LOC and highly relevant to the adolescent youth from military families. Adolescent military dependents will be randomized to receive either the IPT weight gain prevention program or a health education (HE) control condition, for 12 weekly group sessions. Adolescents' weight status, eating behaviors, and mood will be assessed at baseline, immediately following the prevention program (12-weeks), and at 1-year follow-up. At 2-year and 3-year follow-up time points, participants' BMI and physiologic data will be collected via the Military Health System's electronic medical record system. It is hypothesized that adolescents who receive the IPT group program will show significantly less weight gain (or more weight loss) relative to those randomized to HE at 3-year follow-up. Additionally, it is hypothesized that adolescents receiving IPT (as compared to HE) will demonstrate improvements on secondary outcomes of interest, including the presence and frequency of classic binge eating episodes, as well as obesity-related physiological measures of health (e.g., fasting insulin). The overall goal of the study is to prevent excess weight gain and adult obesity, and to prevent worsening disordered eating and metabolic functioning among overweight military dependents at risk for adult obesity and binge eating disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Education | Active comparator | Other: Health EducationThe health education group will follow 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 for adolescent military dependents. |
| Interpersonal Psychotherapy-Weight Gain | Experimental | Behavioral: Interpersonal Psychotherapy-Weight GainIPT-WG is designed to decrease excessive weight gain among adolescents who are at risk for adult obesity. IPT-WG involves developing strategies for dealing with the problems girls struggle with that may lead to increased eating. The IPT-WG program has been adapted to be appropriate for military dependents. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
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 Psychotherapy-Weight GainAlso: IPT-WGParticipants will have 1 individual pre-group session when each participant meets with the group leaders so that they can learn about each girl's significant relationships, set goals for the program, and so each girl can learn about group participation and format. Participants then will begin IPT-WG which is designed to decrease excessive weight gain among adolescents ages 12-17 years who are at risk for adult obesity. The IPT-WG program has been adapted to be appropriate for military dependents. The IPT-WG group meets for 12 consecutive, weekly group meetings and involves developing strategies for dealing with the problems girls struggle with that may lead to increased eating. At the 6th week of the group, the group leaders meet with each participant to review their progress and goals. | Behavioural | Interpersonal Psychotherapy-Weight Gain |
| Health EducationAlso: HEY-Durham (edited for POMC-A)The health education group will follow 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 with a 90 minute session). Girls will come in for a 1.5-hour group meeting once a week for 12 weeks (12 times total). Before beginning the group, girls will meet with group leaders to review each adolescent's family health history. The curriculum includes focus on various health topics, including avoiding alcohol, drug and tobacco use, nutrition and body image, nonviolent conflict resolution, sun safety, exercise, and domestic violence. | Other | Health Education |
Primary outcome
Body mass index metrics
Time frame: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
Participants will be weighed using professional grade equipment and trained personnel.
2 secondary outcomes
Social and emotional functioning
Time frame: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
Blood-based metabolic markers
Time frame: Baseline, Change from baseline at post-intervention, 1-year, and 2-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 23836452Tanofsky-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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy-Weight Gain and Health Education in people with Obesity and Weight Gain, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site 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?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index metrics (time frame: Baseline, Change from baseline at post-intervention, 1-year, and 2-year). 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 NCT02334202, which also lists 1 linked publication.
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 3 Aug 2018.