Healthy Families Healthy Forces Study

NCT02348853 | Completed DMC

• 1 other identifier: 13035001
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Weight change in adult dependents of active duty military

  weight change from baseline to 12 months

  Baseline to 12 months

Secondary Outcomes (17)

• 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

Other Outcomes (7)

• physical activity as measured by the 7-Day Stanford Physical Activity Recall

  baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months

• quality of life as measured by the RAND 36-Item Health Survey, Short Form (SF-36)

  baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months

• Duke Social Support and Stress Scale (DUSOCS)

  baseline to 6 months, 12 months, 24 months and 12 months - 18/24 months

Study Arms (2)

Healthy Weight For Living (HWL)

EXPERIMENTAL

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)

Current Best Practice (CBP)

EXPERIMENTAL

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)

Interventions

Healthy Weight for Living (HWL) BEHAVIORAL

Healthy Weight For Living (HWL)

Current Best Practice (CBP) BEHAVIORAL

Current Best Practice (CBP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• United States Army Research Institute of Environmental Medicine: collaborator

Study Sites (1)

Tufts University Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Das SK, Bukhari AS, Taetzsch AG, Ernst AK, Rogers GT, Gilhooly CH, Hatch-McChesney A, Blanchard CM, Livingston KA, Silver RE, Martin E, McGraw SM, Chin MK, Vail TA, Lutz LJ, Montain SJ, Pittas AG, Lichtenstein AH, Allison DB, Dickinson S, Chen X, Saltzman E, Young AJ, Roberts SB. Randomized trial of a novel lifestyle intervention compared with the Diabetes Prevention Program for weight loss in adult dependents of military service members. Am J Clin Nutr. 2021 Oct 4;114(4):1546-1559. doi: 10.1093/ajcn/nqab259.

  PMID: 34375387 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan B Roberts, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist & Director

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 28, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

US (1)