Program to Reduce Incontinence by Diet and Exercise

Summary

PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.

Conditions

• Urinary Incontinence

Interventions

BEHAVIORAL

Lifestyle & Behavioral Change Program

Participants in the weight loss arm will receive an intensive group-based behavioral weight loss program. In the first six months of the intervention, all participants in the weight loss arm will be given skill-based diet and exercise prescriptions for weight loss and will be taught specific cognitive and behavioral skills to assist in the modification of their eating and exercise habits. Participants will meet weekly for 6 months in group sessions led by a nutritionist, exercise physiologist, or behaviorist and will follow a structured protocol. This intervention strategy is modeled on interventions that have been successful in other overweight populations and is similar to the programs implemented in our ongoing studies, such as Look AHEAD. With this intervention, women are expected to lose on average of 7-9% of their initial body weight.

BEHAVIORAL

Structured Education Program

Women randomized to the Structured Education Program will be invited to participate in hour long group educational sessions at months 1, 2, 3, and 4. At months 6, 9 and 15, the groups will meet again for group support sessions. The content of these education and support sessions will include information about weight loss, physical activity, healthy eating habits and general health promotion. The educational sessions will be delivered primarily in a group format, with individual make up sessions provided for participants who miss group sessions.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Deborah Grady, MD, PhD · UCSF Coordinating Center

• Leslee Subak, MD · UCSF Coordinating Center

• John Kusek, PhD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

• Lee Nyberg, PhD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-07-31

Primary Completion

2007-11-30

Completion

2007-11-30

Countries

• United States

Study Locations