Healthy Families Healthy Forces Study

Description

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 Start Date

January 2015

Estimated Completion Date

April 2019

Interventions

  • Behavioral: Current Best Practice (CBP)
  • Behavioral: Healthy Weight for Living (HWL)

Specialties

  • Endocrinology: Obesity
  • Physician Assistant: Endocrinology

MeSH Terms

  • Obesity
  • Overweight

Study ID

Tufts University -- 13035001

Status

Unknown

Trial ID

NCT02348853

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

580

Sponsor

Tufts University

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Tufts University Human Nutrition Research Center on Aging - Boston, Massachusetts 3.2 miles Sai Krupa Das PhD 617-556-3133 sai.das@tufts.edu

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