NCT01282749

Brief Summary

The purpose of the SisterTalk Hartford study was to assess whether a theoretically- and scientifically-based, culturally acceptable weight loss program could be effectively translated into a faith-based program and subsequently delivered in the church to help African-American women lose weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

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

October 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

January 21, 2011

Last Update Submit

November 21, 2023

Conditions

Keywords

OverweightObesityAfrican AmericanWomenTranslationalFaith basedCommunity based participatory research

Outcome Measures

Primary Outcomes (1)

  • weight loss

    Change in BMI

    assessed 4 times over 2 years, in roughly 6 mo intervals

Study Arms (2)

SisterTalk Hartford First

EXPERIMENTAL

12-week group support and film-based healthy lifestyle education program, including information on healthy nutrition and food preparation, increasing activity and exercise, healthy lifestyle behavior modification, and supportive spiritual materials.

Behavioral: SisterTalk Hartford

SisterTalk Hartford Second

OTHER

Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.

Behavioral: Attention control video series

Interventions

12-week group support and film-based healthy lifestyle education program, including information on healthy nutrition and food preparation, increasing activity and exercise, healthy lifestyle behavior modification, and supportive spiritual materials.

SisterTalk Hartford First

Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.

SisterTalk Hartford Second

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of at least 25.0
  • self-identifies as Black or African-American
  • able to do mild physical activity such as walking or chair exercises

You may not qualify if:

  • has insulin dependent diabetes
  • is pregnant, nursing, or had a baby in the past 4 months
  • has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia)
  • had a heart attack in the past 2 years requiring hospitalization
  • has ever had a stroke
  • has congestive heart failure
  • has uncontrolled hypertension
  • currently participating in another study
  • is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Judith Fifield, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 25, 2011

Study Start

October 1, 2002

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations