Maintenance After Initiation of Nutrition TrAINing

Obesity is the second leading cause of preventable deaths in the United States and is
associated with a wide range of diseases. In people who are obese, weight loss improves
blood pressure, dyslipidemia, glycemia, and arthritis symptoms; reduces medication use for
several disease processes; increases physical functioning; and enhances health-related
quality of life. Despite these benefits, most patients who achieve weight loss regain much
of this weight within a year, and few effective behavioral weight maintenance interventions
have been identified. Thus, there is a dire need for effective interventions that can
promote weight loss maintenance. Theoretical and empirical studies indicate that behavior
maintenance is a distinct state that involves different psychological processes and
behavioral skills than initial behavior change. The few trials that have tested weight loss
maintenance interventions have not taken this distinction into account, which may partially
explain their modest findings. The current study will evaluate a theoretically informed
maintenance intervention. If effective, this intervention could reduce the need for future
clinic visits to treat obesity and its many associated illnesses and could serve as a model
for redesigning the MOVE! program. This 3.5-year study involves a two-arm, randomized,
controlled trial. During the run-in phase, Veterans with BMI 30 kg/m2 will participate in a
4-month, intensive, group-based weight loss program. Participants who lose at least 4 kg by
the end of 4 months (n~230) will be randomized to receive (a) usual care (n~115) for 14
months or (b) a theoretically-informed maintenance intervention (n~115) for 10 months,
followed by 4 months of no intervention contact to examine sustainability. The maintenance
intervention will involve in-person group visits that transition to individualized telephone
calls, and the frequency of contact with the interventionist will gradually taper over time.
Outcomes will be assessed at randomization and at 4, 7, 10, and 14 months
post-randomization. The investigators' hypotheses are that the maintenance intervention will
result in at least 3.5 kg greater weight loss and greater improvements in caloric intake and
physical activity over the study period, and that it will be cost-effective, compared to
usual care.

Inclusion Criteria:

- BMI 30 kg/m2,

- In stable health by medical history,

- Desire to lose weight,

- Agrees to attend regular visits per study protocol,

- Has access to a telephone and reliable transportation,

- Has a VAMC provider.

Exclusion Criteria:

- Age > 75 years old,

- Certain chronic or unstable diseases that may put the participant at increased risk.
These include the following:

- Kidney disease (serum creatinine >2.0 mg/dL in men, >1.7 mg/dL in women),

- Liver disease (cirrhosis, jaundice, or other stigmata of advanced liver
disease),

- Type 1 diabetes,

- Hemoglobin A1c 12%,

- Unstable CHD (unstable angina, coronary ischemia workup in past 3 months),

- Blood pressure 160/100 mmHg, After 3 months, those individuals who were excluded
because of blood pressure levels may be rescreened for eligibility,

- Pregnancy, breastfeeding, or lack of birth control if premenopausal,

- Transplant recipient,

- Pacemaker or defibrillator (bioelectric impedance assessment might interfere with
these),

- Type 1 diabetes

- Dementia, psychiatric illness, or substance abuse that may interfere with adherence
(e.g. illness that is currently unstable or resistant to first-line therapy;
substance abuse in the past year),

- Weight loss attempt in the month prior to screening,

- Enrollment in another research study that might affect the main outcomes of this
study.

- Unable to complete all study measures