Lose Now North Carolina Community Weight Loss Program (Lose Now NC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deborah F Tate, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01615471
First received: June 6, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The Lose Now NC research study aims to determine feasibility by delivering a community based weight loss program for 4 months in Kannapolis, NC in a large group format compared with smaller group format, (recruiting approximately 225 participants from Mecklenburg and Cabarrus counties and randomizing them to large or small group in-person sessions coupled with an interim internet program) to examine reach and recruitment potential, pilot intervention procedures, collect process measures to determine satisfaction, adherence, attrition, and estimate weight loss for planning a larger trial.


Condition Intervention
Obesity
Behavioral: Group weight loss with companion internet

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: Lose-Now-NC: Feasibility of a Large Group Format Community Weight Loss Program Coupled With Internet Support

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Weight change [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in weight from baseline to 4 months


Secondary Outcome Measures:
  • Diet [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in diet as assessed by ASA 24

  • Physical Activity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in Physical Activity as assessed by Paffenbarger Exercise Questionnaire

  • Lipids [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in lipids

  • Hemoglobin A1c [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Change in HbA1c

  • Blood Pressure [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    Change in Blood Pressure from Baseline to 4 months


Estimated Enrollment: 225
Study Start Date: June 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Large Group
In person group sessions in large group format (up to 125 others)
Behavioral: Group weight loss with companion internet
Monthly in-person group sessions with an companion internet weight loss intervention
Active Comparator: Small group
Small group in person sessions (up to 25 other participants)
Behavioral: Group weight loss with companion internet
Monthly in-person group sessions with an companion internet weight loss intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 18-65 years of age. Older adults have more medical co-morbidities; since this community program has minimal face-to-face supervision, individuals age >65 will be ineligible.
  2. Body mass index (BMI) greater than 25.0 kg/m2.
  3. Access to the internet on at least a weekly basis.
  4. Ability to read, write and speak English.
  5. Ability to attend 4 monthly group sessions and 2 assessment visits (baseline and follow-up) at the Nutrition Research Institute.
  6. Possession and usage of an internet e-mail address or willingness to sign up for a free email account (e.g., gmail)

Exclusion Criteria:

  1. Pregnancy during the previous 3 months, or planned pregnancy in the folliowing 6 month (study period including assessments and treatment).
  2. Current participation in another weight loss study or program (including weight loss medication) and unwilling to discontinue participation for the duration of the study.
  3. Insulin treatment for diabetes mellitus.
  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: NCT01615471

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: Deborah F Tate, PhD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01615471     History of Changes
Other Study ID Numbers: LNNC2012
Study First Received: June 6, 2012
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Obesity
Lifestyle Intervention
Group treatment
Internet Intervention

Additional relevant MeSH terms:
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014