Healthy Families Healthy Forces Study

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.

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.