NCT01615471

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2012

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

June 6, 2012

Last Update Submit

February 23, 2017

Conditions

Obesity

Keywords

ObesityLifestyle InterventionGroup treatmentInternet Intervention

Outcome Measures

Primary Outcomes (1)

  • Weight change

    Change in weight from baseline to 4 months

    4 months

Secondary Outcomes (5)

  • Diet

    4 months

  • Physical Activity

    4 months

  • Lipids

    4 months

  • Hemoglobin A1c

    4 months

  • Blood Pressure

    Baseline to 4 months

Study Arms (2)

Large Group

ACTIVE COMPARATOR

In person group sessions in large group format (up to 125 others)

Behavioral: Group weight loss with companion internet

Small group

ACTIVE COMPARATOR

Small group in person sessions (up to 25 other participants)

Behavioral: Group weight loss with companion internet

Interventions

Group weight loss with companion internetBEHAVIORAL

Monthly in-person group sessions with an companion internet weight loss intervention

Large GroupSmall group

Eligibility Criteria

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

You may qualify if:

  • 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.
  • Body mass index (BMI) greater than 25.0 kg/m2.
  • Access to the internet on at least a weekly basis.
  • Ability to read, write and speak English.
  • Ability to attend 4 monthly group sessions and 2 assessment visits (baseline and follow-up) at the Nutrition Research Institute.
  • Possession and usage of an internet e-mail address or willingness to sign up for a free email account (e.g., gmail)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Tate DF, Valle CG, Crane MM, Nezami BT, Samuel-Hodge CD, Hatley KE, Diamond M, Polzien K. Randomized trial comparing group size of periodic in-person sessions in a remotely delivered weight loss intervention. Int J Behav Nutr Phys Act. 2017 Oct 23;14(1):144. doi: 10.1186/s12966-017-0599-3.

    PMID: 29061153DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

US(1)