Boston, Massachusetts 02111


Purpose:

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.


Study summary:

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 2 years 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 2 years than the CBP intervention in an intent-to-treat analysis in adult dependents and their AD or retired military personnel, and that the greater weight loss in HWL will be associated with improved management of hunger and greater adherence to the goal of reducing energy intake. 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 2 years in adult dependents of AD or retired military personnel. The primary outcome will be weight change from baseline to 2 years. The working hypothesis is that randomization to the HWL intervention will result in significantly greater weight loss over 2 years 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. 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. 3. 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 2 years 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.


Criteria:

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.


NCT ID:

NCT02348853


Primary Contact:

Principal Investigator
Susan B Roberts, PhD
Tufts University

Sai K Das, PhD
Phone: 6175563143
Email: hf2study@tufts.edu


Backup Contact:

Email: hf2study@tufts.edu
Edward M Martin, MS
Phone: 6175563143


Location Contact:

Boston, Massachusetts 02111
United States

Sai Krupa Das, PhD
Phone: 617-556-3133
Email: hf2study@tufts.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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