Healthy Families Healthy Forces Study

Study Overview
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Brief Summary
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U.S. Army Medical Research & Materiel Command Telemedicine and Advanced Technology Research Center (TATRC) is sponsoring the HF2 (Healthy Families, Healthy Forces) Study. This is a randomized trial comparing two different interventions for sustainable weight loss. Specifically, the investigators will compare a current best practice (CBP) intervention that includes standard dietary advice with a new, Healthy Weight for Living (HWL) intervention that includes recommendations to eat a diet rich in protein, dietary fiber, low glycemic index carbohydrates and low calorie foods. The objective of this study is to compare the CBP and HWL interventions when delivered to adult dependents of active duty (AD) military personnel and measure weight loss effects in both the adult dependents and the AD military personnel they live with.

Detailed Description
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This is a randomized trial comparing two different interventions for sustainable weight loss. Specifically researchers will compare a current best practice (CBP) intervention that includes standard dietary advice with a new Healthy Weight for Living (HWL) intervention that includes recommendations to eat a diet rich in protein, dietary fiber and low glycemic index carbohydrates. The population will be adult dependents of Active Duty (AD) military personnel or retired military personnel (direct intervention participants) and the AD or retired military personnel they live with (indirect intervention participants). The primary outcome will be weight change from baseline to 1 year in the adult dependents. The objective of this study is to compare the CBP and HWL interventions when delivered to adult dependents of AD or retired military personnel and measure weight loss effects in both the adult dependents and the AD or retired military personnel they live with. The working hypothesis is that that the HWL intervention will result in significantly greater weight loss over 1 year than the CBP intervention in an intent-to-treat analysis in adult dependents, and that the greater weight loss in HWL will be associated with greater management of hunger and greater adherence to the goal of reducing energy intake. Weight change up until the 18-24 month period will be measured as a secondary outcome in a cohort of participants who will reach the 18-24 month milestone in the study on or prior to December, 2018. A per protocol analysis will also be applied for comparison of the two weight loss arms. (In addition, weight change will be measured in the participants' AD or retired military personnel partner to test the hypothesis that there is a ripple effect of benefits from the interventions associated with effects in the primary recipients.) The original study plan was to examine weight change over 2 years but due to slower recruiting than anticipated the hypotheses were revised to allow for 1 year to be the primary outcome, with secondary outcomes in the subgroup followed until 18-24 months. The researchers plan to test our central hypothesis and accomplish the study objectives with the following technical objectives: Conduct a randomized trial comparing the HWL intervention to the CBP intervention over 1 year in adult dependents of AD or retired military personnel. The primary outcome will be weight change from baseline to 1 year. The working hypothesis is that randomization to the HWL intervention will result in significantly greater weight loss over 1 year than randomization to the CBP intervention, and that greater weight loss in the HWL intervention will be associated with greater adherence to the goals of reducing energy intake and hunger. Compare the change in weight loss of participants in the HWL intervention to the CBP intervention over the 18-24 month timepoints in the subgroup of participants who will reach the 18-24 month milestone on or prior to December, 2018. The working hypothesis is that randomization to the HWL intervention will result in significantly improved weight loss retention compared to randomization to the CBP intervention. Examine the effects of the interventions delivered to adult dependents of AD or retired military personnel on the weight of AD or retired military personnel themselves. The working hypothesis, based on preliminary data, is that there will be a ripple effect of program benefits from intervention participants to the AD or retired military personnel they live with; specifically, overweight and obese AD or retired military personnel will lose more weight if their partner is randomized to the HWL intervention compared to the CBP intervention, because the weight loss of AD or retired military personnel indirectly exposed to the intervention will be proportional to the weight loss of their adult dependent who is directly exposed. Compare the effects of the two interventions on changes in cardiometabolic risk factors. The working hypothesis is that there will be significantly greater improvements between baseline and 1 year in key cardiometabolic risk factors in adult dependents enrolled in the HWL intervention compared to the CBP intervention, and differences between groups will be predicted by differences in weight loss. For a select subgroup of participants who reach the 18-24 month timepoint on or prior to December 2018, the working hypothesis is that there will be significantly greater improvements in between baseline and 2 years in key cardiometabolic risk factors in adult dependents enrolled in the HWL compared to the CBP intervention.

Official Title
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Intervention for Sustainable Weight Loss in Military Families

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Healthy Weight for Living (HWL)
* Behavioral: Current Best Practice (CBP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult dependent of active duty (AD) military personnel: an individual who is at least 18 years and have a military identification(ID) card indicating they are a dependent. This includes AD military sponsor's children at least 18 years of age (by birth or adoption), spouse, partner, parents, and parent-in-laws) At the time of enrollment, willing to be randomized to one of the intervention groups and complete outcome assessments, at least 18 years old at time of provision of informed consent BMI at screening greater than or equal to 25.0 kg/m2 English speaking AD military personnel: AD military personnel do not have to meet any criteria other than having an adult partner enrolled in the weight loss program. Exclusion Criteria: Adult dependent of AD military personnel: BMI <25 Pregnant Expecting to become pregnant within duration of the study, or lactating Prior weight loss surgery Concurrent participation in another weight loss program or research study Non-English speaking Currently undergoing divorce proceedings Very active individuals (> 2 hours/day vigorous activity) Individuals who have lost > 10 lb in the past 6 months Individuals with thyroid disease who have had changes in medications within the past 3 months Individuals with Type 1 diabetes and individuals with Type 2 diabetes who started using insulin in childhood (before 18 years) Those with stomach or intestinal resection, including gastric bypass or other weight loss surgery that influences food intake or absorption of food Those with eating disorder such as anorexia, bulimia or binge-eating disorder currently or within the past 5 years Those with diagnosis of celiac disease, inflammatory bowel disease or any condition that influences ability to absorb food Those with current moderate to severe depression that prevents individual engaging in work or usual activities Those with recent unstable heart disease, myocardial infarction Active cancer Taking medication for severe kidney disease Chronic obstructive pulmonary disease Immunologic disorders AIDS Schizophrenia Psychosis or bipolar disorder Individuals who drink >3 drinks daily or >20 drinks/week Individuals with other diseases or taking other medications that impact ability to comply with the intervention core goal of achieving weight loss of 1-2 lb per week through some combination of changing types and amounts of consumed foods and exercise Excluded medications include steroids except topical preparations. AD military personnel: Those not currently living with the dependent due to separation and/or divorce proceedings will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Weight For Living (HWL)<br>HWL is a behavioral intervention designed to effectively facilitate hunger suppression with several concurrent approaches. Hunger suppression is a core behavioral goal of the intervention, and strategies will be used to support that goal, for example increasing meal frequency and encouraging the use of highly satiating low-energy foods to reduce hunger acutely. A unique combination of healthy dietary goals will be recommended that support hunger suppression and/or maintenance of satiety: high total dietary fiber, moderately high protein, moderately low glycemic load (GL) and low energy density. | Behavioral: Healthy Weight for Living (HWL)<br> <br> |
| Experimental: Current Best Practice (CBP)<br>This intervention is an adapted version of Group Lifestyle Balance which is a validated weight loss program for community groups and military populations that is an official adaptation of the gold standard Diabetes Prevention Program Lifestyle Balance intensive research intervention. It has both training programs for interventionists and program material available on the web and is also slightly modified from the Diabetes Prevention Program study to take into account changing national nutrition recommendations. | Behavioral: Current Best Practice (CBP)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change in adult dependents of active duty military | weight change from baseline to 12 months | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in systolic and diastolic blood pressure (mmHg) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in total cholesterol (mg/dL) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in HDL cholesterol (mg/dL) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in LDL cholesterol (mg/dL) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in triacylglycerol (mg/dL) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in serum glucose (mg/dL) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in serum insulin (μIU/mL) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in homeostasis model assessment-estimated insulin resistance (HOMA-IR) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in C-reactive protein (CRP) |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| change in HbA1c |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| emotional eating as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18) | TFEQ-r18 measures the cognitive and behavioral aspects of eating and has three subscales: cognitive restraint (CR), uncontrolled eating (UE), and emotional eating (EE). The score range for EE is 3 - 12, and higher scores indicate greater emotional eating. The EE subscale has 3 items, each on a 4-point Likert scale (1 - 4). The items are summed up for each subscale, and the total CR, UE, and EE scores are considered separately. | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| food cravings as measured by the Food Craving Questionnaire (FCQ) | Food Cravings Questionnaire - State (FCQ-S) measures situational food cravings. It has 15 items, each of which is on a 5-point Likert scale (1 - 5), and the score range is 15 - 75. Higher scores indicate situational food cravings of greater intensity. Scores on all items are summed up for a total score. Food Cravings Questionnaire - Trait (FCQ-T) measures frequency and intensity of food cravings. It has 39 items, each of which is on a 6-point Likert scale (1 - 6), and the score range is 39 - 234. Higher scores indicate more frequent and intense food cravings. Scores on all items are summed up for a total score. | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| dietary intake as measured by 24-hour recalls and supermarket receipts |  | baseline to 6 months, 12 months, and 18/24 months | 
| uncontrolled eating as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18) | TFEQ-r18 measures the cognitive and behavioral aspects of eating and has three subscales: cognitive restraint (CR), uncontrolled eating (UE), and emotional eating (EE). The score range for UE is 9 - 36, and higher scores indicate greater uncontrolled eating. The UE subscale has 9 items, each on a 4-point Likert scale (1 - 4). The items are summed up for each subscale, and the total CR, UE, and EE scores are considered separately. | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| cognitive restraint as measured by the Three Factor Eating Questionnaire - r18 (TFEQ-r18) | TFEQ-r18 measures the cognitive and behavioral aspects of eating and has three subscales: cognitive restraint (CR), uncontrolled eating (UE), and emotional eating (EE). The score range for CR is 6 - 24, and higher scores indicate greater cognitive restraint. The CR subscale has 6 items, each on a 4-point Likert scale (1 - 4). The items are summed up for each subscale, and the total CR, UE, and EE scores are considered separately. | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months | 
| Weight change in adult dependents of active duty military, 18-24 months | Weight change up until the 18-24 month period will be measured in a cohort of participants who will reach the 18-24 month milestone in the study on or prior to December, 2018 | baseline to 18 months, 24 months | 
| weight change in active duty military |  | baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months |