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Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01357551
First received: May 13, 2011
Last updated: September 13, 2016
Last verified: September 2016
  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 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.

Condition Intervention
Obesity
Behavioral: Maintenance intervention

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)

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Weight [ Time Frame: 56 weeks post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimated Daily Caloric Intake [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
    Based on self-report using Block Brief Food Frequency Questionnaire

  • Estimated Metabolic Minutes of Walking Per Week [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
    self-reported based on short form of International Physical Activity Questionnaire

  • Estimated Metabolic Minutes of Moderate Physical Activity Per Week [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
    self-reported based on short form of International Physical Activity Questionnaire


Enrollment: 222
Study Start Date: August 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maintenance intervention
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
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.
No Intervention: Usual care
Participants receive usual care for 56 weeks

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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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, Durham, NC
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Corrine I Voils, PhD Durham VA Medical Center, Durham, NC
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01357551     History of Changes
Other Study ID Numbers: IIR 11-040 
Study First Received: May 13, 2011
Results First Received: September 13, 2016
Last Updated: September 13, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
obesity
intervention studies
patient adherence

ClinicalTrials.gov processed this record on December 06, 2016