N/A
N=222
Maintenance After Initiation of Nutrition TrAINing
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01357551 ↗Enrolled (actual)
222
Serious AEs
2.3%
Results posted
Nov 2016
Primary outcome: Primary: Weight — 99.2; 105.7 kilograms — p=.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Maintenance intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
99.2; 105.7 | .04 sig |
| SECONDARY Estimated Daily Caloric Intake |
1207.5; 1339.1 | .11 |
| SECONDARY Estimated Metabolic Minutes of Walking Per Week |
680.72; 665.43 | .91 |
| SECONDARY Estimated Metabolic Minutes of Moderate Physical Activity Per Week |
783.40; 810.25 | .83 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01357551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.