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Maintenance After Initiation of Nutrition TrAINing

Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Interventions (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Corrine I. Voils, PhD, Principal Investigator, Affiliation: Department of Veterans Affairs

Overall contact:
Jamiyla B McKenzie, BA, Phone: (919) 286-6936, Email: Jamiyla.McKenzie@va.gov

Summary

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. 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.

Clinical Details

Official title: Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: weight

Detailed description: 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, 330 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. Our 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.

Eligibility

Minimum age: 18 Years. Maximum age: 74 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. BMI 30 kg/m2,

2. In stable health by medical history,

3. Desire to lose weight,

4. Agrees to attend regular visits per study protocol,

5. Has access to a telephone and reliable transportation,

6. Has a VAMC provider.

Exclusion Criteria:

1. Age > 75 years old,

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

1. Kidney disease (serum creatinine >2. 0 mg/dL in men, >1. 7 mg/dL in women),

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

3. Type 1 diabetes,

4. Hemoglobin A1c 12%,

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

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

3. Pregnancy, breastfeeding, or lack of birth control if premenopausal,

4. Transplant recipient,

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

6. Type 1 diabetes

7. 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),

8. Weight loss attempt in the month prior to screening,

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

10. Unable to complete all study measures

Locations and Contacts

Jamiyla B McKenzie, BA, Phone: (919) 286-6936, Email: Jamiyla.McKenzie@va.gov

Durham VA Medical Center HSR&D COE, Durham, North Carolina 27705, United States; Recruiting
Jamiyla B McKenzie, BA, Phone: 919-286-6936, Email: Jamiyla.McKenzie@va.gov
Corrine I Voils, PhD, Phone: (919) 286-6936, Email: corrine.voils@va.gov
Corrine I. Voils, PhD, Principal Investigator
Jennifer L. Strauss, BA MS PhD, Sub-Investigator
Jennifer M Gierisch, BS MPH PhD, Sub-Investigator
Matthew L. Maciejewski, PhD, Sub-Investigator
William S. Yancy, MD MHS, Sub-Investigator
Additional Information

Starting date: August 2012
Last updated: January 31, 2013

Page last updated: February 07, 2013

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