NCT01357551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 2, 2016

Completed
Last Updated

November 2, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

May 13, 2011

Results QC Date

September 13, 2016

Last Update Submit

September 13, 2016

Conditions

Obesity

Keywords

obesityintervention studiespatient adherence

Outcome Measures

Primary Outcomes (1)

  • Weight

    56 weeks post-randomization

Secondary Outcomes (3)

  • Estimated Daily Caloric Intake

    56 weeks

  • Estimated Metabolic Minutes of Walking Per Week

    56 weeks

  • Estimated Metabolic Minutes of Moderate Physical Activity Per Week

    56 weeks

Study Arms (2)

Maintenance intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Participants receive usual care for 56 weeks

Interventions

Maintenance interventionBEHAVIORAL

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.

Maintenance intervention

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (5)

  • 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.

    PMID: 24347145RESULT

  • 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.

    PMID: 25117805RESULT

  • Gavin KL, Almeida EJ, Voils CI, Crane MM, Shaw R, Yancy WS Jr, Pendergast J, Olsen MK. Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method. Obes Sci Pract. 2023 Jan 12;9(4):337-345. doi: 10.1002/osp4.656. eCollection 2023 Aug.

    PMID: 37546286DERIVED

  • 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.

    PMID: 28853051DERIVED

  • 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.

    PMID: 28241185DERIVED

MeSH Terms

Conditions

ObesityPatient Compliance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

May not generalize to other populations; relatively short length of follow-up; use of self-reported secondary outcome measures

Results Point of Contact

Title
Dr. Corrine Voils
Organization
Durham VA Medical Center
corrine.voils@va.gov
9192860411

Study Officials

  • Corrine I Voils, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 20, 2011

Study Start

August 1, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 2, 2016

Results First Posted

November 2, 2016

Record last verified: 2016-09

Locations

US(1)