NCT01141348

Brief Summary

The overall goal of the translational research is to evaluate the processes and outcomes of implementing, in a range of public health agencies, an intense, evidence-based behavioral weight loss intervention with demonstrated effectiveness among midlife low-income women. The intervention was originally studied in a single coordinated community health care center/church setting and delivered by research staff. The investigators will evaluate the intervention's translation and test its effectiveness as implemented by existing staff in six public health agencies supported by local community resources.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

6 active sites

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

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

1 year

First QC Date

May 6, 2010

Last Update Submit

June 9, 2010

Conditions

OverweightObesityCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Weight Change difference between baseline and 4 month follow-up

    Baseline and 4 month follow-up

Secondary Outcomes (1)

  • Change in blood pressure, dietary intake, physical activity, and quality of life between baseline and 4 month follow-up

    Baseline and 4 month follow-up

Study Arms (2)

Special Intervention

EXPERIMENTAL
Behavioral: Special Intervention

Delayed Intervention

EXPERIMENTAL
Behavioral: Delayed Intervention

Interventions

Special InterventionBEHAVIORAL

16 week behavioral weight loss intervention included 2 hour weekly group sessions

Special Intervention
Delayed InterventionBEHAVIORAL

During the randomized controlled trial, the Delayed Intervention (DI) group received two newsletters with study updates and general health information. Following the trial, the DI group received a 10-week weight loss program.

Delayed Intervention

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 27.5 and 45
  • willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and PA patterns
  • English-speaking
  • able and willing to give informed consent
  • household income less than or equal to 250% of federal poverty guidelines.

You may not qualify if:

  • medical or physical limitations to engaging in moderate level physical activity
  • medical or other contraindications to weight loss
  • history of gastric bypass surgery or scheduled surgery for this purpose
  • weight loss of \> 20 lbs in the last 3 months
  • current use of medication for weight loss
  • treatment of psychosis
  • diagnosis of Type 1 diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Albemarle Regional Health Services

Elizabeth City, North Carolina, 27907, United States

Location

Davidson County Health Department

Lexington, North Carolina, 27293, United States

Location

Lincoln County Health Department

Lincolnton, North Carolina, 28092, United States

Location

Nash County Health Department

Nashville, North Carolina, 27856, United States

Location

Warren County Health Department

Warrenton, North Carolina, 27589, United States

Location

Forsyth County Health Department

Winston-Salem, North Carolina, 27102, United States

Location

Related Publications (1)

  • Jones SA, Evenson KR, Johnston LF, Trost SG, Samuel-Hodge C, Jewell DA, Kraschnewski JL, Keyserling TC. Psychometric properties of the modified RESIDE physical activity questionnaire among low-income overweight women. J Sci Med Sport. 2015 Jan;18(1):37-42. doi: 10.1016/j.jsams.2013.12.007. Epub 2014 Jan 1.

    PMID: 24462117DERIVED

MeSH Terms

Conditions

OverweightObesityCardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • Carmen Samuel-Hodge, PhD, MS, RD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2010

First Posted

June 10, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

US(6)