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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01487538
Other study ID # 0175-09-FB
Secondary ID 5P20NR011404
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2012
Est. completion date February 1, 2014

Study information

Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare an technology-based weight maintenance intervention using action plans, videos discussion boards and health behavior tracking (weight, calories in and out, pedometer steps) with a technology-based standard advice group to facilitate health management, resourcefulness and health status for rural middle-aged women.


Description:

The purpose of this research project is to evaluate the influence of a theory-based intervention using the Health Effects of Life Transitions for Women Model to promote maintenance of initial weight loss. The intervention will be designed to promote physical activity to prevent weight regain among an underserved and vulnerable population of rural, mid-life women. The intervention delivered through action plans, videos, discussion boards and health behavior tracking (weight, calories in and out, pedometer steps) to facilitate health management, resourcefulness and health status will be compared with the standard advice group who receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date February 1, 2014
Est. primary completion date February 1, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 64 Years
Eligibility Inclusion Criteria: Women: - aged 40-64 years; - reported intentional weight loss of 5-10% of initial body weight within previous 6 months; - residing in a rural county (population < 50,000 residents) or rural community (population less than 2,500) within driving distance of a UNMC College of Nursing campus; - ability to communicate in English (verbal and written); - ambulatory and can walk at least one block without the use of an assistive device, such as a cane, walker, or wheelchair; - have access to the internet and current email account; and - answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician to become more active. Exclusion Criteria: - instructed by a physician not to exercise; - presence of chest pain, shortness of breath, or feelings of light-headedness upon exertion.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Videos
Provide information on physical activity, diet, calorie tracking to support weight maintenance in rural women.
Action Plans
Online action plans will be used by subjects to set and evaluate physical activity goals
Discussion Boards
forum to exchange information and experiences
Health behavior tracking
online tracking of weight for both intervention and standard advice group. In addition, the intervention group will also track their calories in and out and their pedometer steps

Locations

Country Name City State
United States Southeast District Health Department Auburn Nebraska

Sponsors (2)

Lead Sponsor Collaborator
University of Nebraska National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary weight maintenance Weight maintenance (no significant change in weight from baseline which corresponds to a weight gain of less than 2.3 kg from baseline over the course of the study) baseline, 3 months, 6 months
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