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

This study has been completed.
Information provided by (Responsible Party):
Deborah F Tate, PhD, University of North Carolina, Chapel Hill Identifier:
First received: June 6, 2012
Last updated: February 23, 2017
Last verified: February 2017
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
Behavioral: Group weight loss with companion internet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ]
    Change in weight from baseline to 4 months

Secondary Outcome Measures:
  • Diet [ Time Frame: 4 months ]
    Change in diet as assessed by ASA 24

  • Physical Activity [ Time Frame: 4 months ]
    Change in Physical Activity as assessed by Paffenbarger Exercise Questionnaire

  • Lipids [ Time Frame: 4 months ]
    Change in lipids

  • Hemoglobin A1c [ Time Frame: 4 months ]
    Change in HbA1c

  • Blood Pressure [ Time Frame: Baseline to 4 months ]
    Change in Blood Pressure from Baseline to 4 months

Enrollment: 195
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01615471

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:
Responsible Party: Deborah F Tate, PhD, Associate Professor, University of North Carolina, Chapel Hill Identifier: NCT01615471     History of Changes
Other Study ID Numbers: LNNC2012
Study First Received: June 6, 2012
Last Updated: February 23, 2017

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

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms processed this record on May 24, 2017