Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01357551
First received: May 13, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Obesity
Behavioral: Interventions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • weight [ Time Frame: 14 months post-randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Participants are randomized to 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.
Behavioral: Interventions
Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.
No Intervention: Arm 2
Participants are randomized to receive usual care (n~115) for 14 months

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, 650 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

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357551

Locations
United States, North Carolina
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: Corrine I. Voils, PhD Department of Veterans Affairs
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01357551     History of Changes
Other Study ID Numbers: IIR 11-040
Study First Received: May 13, 2011
Last Updated: May 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
obesity
intervention studies
patient adherence

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014