- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01487538
Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
August 30, 2023 updated by: University of Nebraska
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Auburn, Nebraska, United States, 68305
- Southeast District Health Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
The intervention will be 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.
|
Provide information on physical activity, diet, calorie tracking to support weight maintenance in rural women.
Online action plans will be used by subjects to set and evaluate physical activity goals
forum to exchange information and experiences
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
|
Active Comparator: Standard Advice Group
Standard advice group receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
weight maintenance
Time Frame: baseline, 3 months, 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Teresa Hultquist, PhD, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
November 30, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (Estimated)
December 7, 2011
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0175-09-FB
- 5P20NR011404 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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