Back to resultsWeight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
Primary Purpose
Body Weight Changes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Videos
Action Plans
Discussion Boards
Health behavior tracking
Sponsored by
About this trial
This is an interventional health services research trial for Body Weight Changes
Eligibility Criteria
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.
Sites / Locations
- Southeast District Health Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention group
Standard Advice Group
Arm Description
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.
Standard advice group receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01487538
First Posted
November 30, 2011
Last Updated
August 30, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01487538
Brief Title
Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
Official Title
Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2012 (Actual)
Primary Completion Date
February 1, 2014 (Actual)
Study Completion Date
February 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Advice Group
Arm Type
Active Comparator
Arm Description
Standard advice group receives newsletters and health behavior tracking (weight) to initiate, increase, or sustain physical activity for weight maintenance.
Intervention Type
Behavioral
Intervention Name(s)
Videos
Intervention Description
Provide information on physical activity, diet, calorie tracking to support weight maintenance in rural women.
Intervention Type
Behavioral
Intervention Name(s)
Action Plans
Intervention Description
Online action plans will be used by subjects to set and evaluate physical activity goals
Intervention Type
Behavioral
Intervention Name(s)
Discussion Boards
Intervention Description
forum to exchange information and experiences
Intervention Type
Behavioral
Intervention Name(s)
Health behavior tracking
Intervention Description
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
Primary Outcome Measure Information:
Title
weight maintenance
Description
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)
Time Frame
baseline, 3 months, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Hultquist, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southeast District Health Department
City
Auburn
State/Province
Nebraska
ZIP/Postal Code
68305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weight Maintenance Through Physical Activity and Social Support in Rural Middle-Aged Women
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