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Completed

NCT Number: NCT01357551

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. 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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maintenance Intervention

Behavioral

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.

Primary outcomes

  1. Weight

    Time frame: 56 weeks post-randomization

Secondary outcomes

  1. Estimated Daily Caloric Intake

    Time frame: 56 weeks

    Based on self-report using Block Brief Food Frequency Questionnaire

  2. Estimated Metabolic Minutes of Walking Per Week

    Time frame: 56 weeks

    self-reported based on short form of International Physical Activity Questionnaire

  3. Estimated Metabolic Minutes of Moderate Physical Activity Per Week

    Time frame: 56 weeks

    self-reported based on short form of International Physical Activity Questionnaire

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)

Acronym: MAINTAIN

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 20, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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