NCT00164515

Brief Summary

This study aims to increase physical activity among overweight African-American women with mobility limitations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Oct 2004

Typical duration for phase_2 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

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

September 12, 2005

Last Update Submit

July 24, 2019

Conditions

Keywords

obesity, mobility limitations, women, physical activity

Outcome Measures

Primary Outcomes (5)

  • Physical activity

    Physical activity was assessed using the Physical Activity and Disability Scale (PADS), the Barriers to Physical Activity and Disbility Scale (B-PADS), (Rimmer et al 2000) and the Mobility Limitation score (Velozo et al 1999).

    24 months

  • Body mass index (BMI)

    Derived emperically

    24 months

  • Blood lipids

    Derived emperically

    24 months

  • Weight

    Derived emperically

    24 months

  • Blood Pressure

    Dervied emperically

    24 months

Secondary Outcomes (1)

  • Psychosocial Health

    24 months

Study Arms (3)

Arm 1: Physical activity awareness

NO INTERVENTION

The awareness group received a physician-recommendation to exercise an informational brochure, and pedometer.

Arm 2: Lower Support

EXPERIMENTAL

The lower support group received arm 1 plus monthly newsletter, weekly personalized exercise support via telephone.

Behavioral: Personalized exercise programme (PEP)

Arm 3: Higher support

EXPERIMENTAL

The higher support group received arm 1 plus arm 2 plus a face-to-face monthly exercise support group.

Behavioral: Personalized exercise programme (PEP)

Interventions

Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago

Also known as: PEP
Arm 2: Lower SupportArm 3: Higher support

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • English speaking
  • Self-reported mobility limitation
  • BMI greater than or equal to 27
  • Receiving care at the University of Illinois, Chicago (UIC) Medical Center
  • Sedentary

You may not qualify if:

  • did not receive physician approval to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Rimmer JH, Rauworth A, Wang E, Heckerling PS, Gerber BS. A randomized controlled trial to increase physical activity and reduce obesity in a predominantly African American group of women with mobility disabilities and severe obesity. Prev Med. 2009 May;48(5):473-9. doi: 10.1016/j.ypmed.2009.02.008.

MeSH Terms

Conditions

ObesityMobility LimitationMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • James Rimmer, Ph.D.

    UIChicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

October 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations