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.
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: 1. 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. 2. 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. 3. 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. 4. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
308
Tufts University Human Nutrition Research Center on Aging
Boston, Massachusetts, United States
Weight change in adult dependents of active duty military
weight change from baseline to 12 months
Time frame: Baseline to 12 months
change in systolic and diastolic blood pressure (mmHg)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in total cholesterol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in HDL cholesterol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in LDL cholesterol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in triacylglycerol (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in serum glucose (mg/dL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in serum insulin (μIU/mL)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in homeostasis model assessment-estimated insulin resistance (HOMA-IR)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in C-reactive protein (CRP)
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
change in HbA1c
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: baseline to 18 months, 24 months
weight change in active duty military
Time frame: baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months
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