Maintenance After Initiation of Nutrition TrAINing

Study Overview
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Brief Summary
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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 evaluated 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.

Detailed Description
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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 evaluated the efficacy of a theoretically informed maintenance intervention compared to usual care. If efficacious, 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 involved a two-arm, randomized, controlled trial. During the run-in phase, Veterans with BMI 30 kg/m2 participated in a 4-month, intensive, group-based weight loss program. Participants who lost at least 4 kg by the end of 4 months (n=222) were randomized to receive (a) usual care (n=112) for 56 weeks or (b) a theoretically-informed maintenance intervention (n=110) for 42 weeks months, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention involved in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually tapered over time. Outcomes were assessed at randomization and at weeks 14, 26, 42, and 56 post-randomization. The 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.

Official Title
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Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Maintenance intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >= 30 kg/m2 Desire to lose weight Agrees to attend regular visits per study protocol Has a provider at the Durham Veterans Affairs Medical Center Exclusion Criteria: Age >= 75 years old, Most recent 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% in past 6 months unstable angina or coronary ischemia workup in past 3 months Female: pregnancy, breastfeeding, or lack of birth control if premenopausal Transplant recipient Pacemaker or defibrillator (bioelectric impedance assessment might interfere with these) Average systolic blood pressure in the past year >= 160 mmHg AND most recent BP >=160 mmHg Dementia, severe psychiatric illness (e.g., major depression), alcohol problem, or illicit substance abuse Weight loss of at least 10 lb in previous 3 months Enrollment in a weight loss program Unable to stand for study measurements history of weight loss surgery cancer not in remission current use of appetite suppressants or weight loss medication lack of reliable transportation or telephone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maintenance intervention<br>Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time. | Behavioral: Maintenance intervention<br>* Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.<br>|
| No Intervention: Usual care<br>Participants receive usual care for 56 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 56 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Daily Caloric Intake | Based on self-report using Block Brief Food Frequency Questionnaire | 56 weeks | 
| Estimated Metabolic Minutes of Walking Per Week | self-reported based on short form of International Physical Activity Questionnaire | 56 weeks | 
| Estimated Metabolic Minutes of Moderate Physical Activity Per Week | self-reported based on short form of International Physical Activity Questionnaire | 56 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, intervention studies, patient adherence