Clinical trial NCT01357551: Maintenance After Initiation of Nutrition TrAINing
Official title: Maintenance After Initiation of Nutrition TrAINing (MAINTAIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
intervention studies
patient adherence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-05-20
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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: 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 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

Primary outcomes:
measure: Weight
timeFrame: 56 weeks post-randomization
Secondary outcomes:
measure: Estimated Daily Caloric Intake
timeFrame: 56 weeks
measure: Estimated Metabolic Minutes of Walking Per Week
timeFrame: 56 weeks
measure: Estimated Metabolic Minutes of Moderate Physical Activity Per Week
timeFrame: 56 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Corrine I Voils, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Voils CI, Gierisch JM, Yancy WS Jr, Sandelowski M, Smith R, Bolton J, Strauss JL. Differentiating Behavior Initiation and Maintenance: Theoretical Framework and Proof of Concept. Health Educ Behav. 2014 Jun;41(3):325-36. doi: 10.1177/1090198113515242. Epub 2013 Dec 16.
citation: Voils CI, Gierisch JM, Olsen MK, Maciejewski ML, Grubber J, McVay MA, Strauss JL, Bolton J, Gaillard L, Strawbridge E, Yancy WS Jr. Study design and protocol for a theory-based behavioral intervention focusing on maintenance of weight loss: the Maintenance After Initiation of Nutrition TrAINing (MAINTAIN) study. Contemp Clin Trials. 2014 Sep;39(1):95-105. doi: 10.1016/j.cct.2014.08.002. Epub 2014 Aug 10.
citation: Funk LM, Grubber JM, McVay MA, Olsen MK, Yancy WS, Voils CI. Patient predictors of weight loss following a behavioral weight management intervention among US Veterans with severe obesity. Eat Weight Disord. 2018 Oct;23(5):587-595. doi: 10.1007/s40519-017-0425-6. Epub 2017 Aug 29.
citation: Voils CI, Olsen MK, Gierisch JM, McVay MA, Grubber JM, Gaillard L, Bolton J, Maciejewski ML, Strawbridge E, Yancy WS Jr. Maintenance of Weight Loss After Initiation of Nutrition Training: A Randomized Trial. Ann Intern Med. 2017 Apr 4;166(7):463-471. doi: 10.7326/M16-2160. Epub 2017 Feb 21.