Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women, Also Known as Wome… (NCT01307644) | Clinical Trial Compass
CompletedNot Applicable
Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women, Also Known as Women Weigh-in for Wellness
United States301 participantsStarted 2011-05-01
Plain-language summary
This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.
Who can participate
Age range
40 Years – 69 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women aged 40-69
* overweight or Class I \& II obese (BMI 28 to 39.9)or BMI 40 to 45 with physician clearance
* state a commitment to losing weight
* speak and read English
* able to communicate over the telephone
* able to use a computer with minimal assistance and complete electronic forms and surveys
* have access to and are able to access the Internet
* commitment to access the website as required by the research intervention including weekly self-reporting of calories and fat grams, weekly self-reporting of physical activity, pedometer steps, and body weight, and weekly (or more often) participation in other website components as determined by group to which randomized and phase of intervention
* have or are willing to obtain an email account
* have access to a DVD player
* able to walk without an assistive device
* 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:
* diagnosed with Type 1 diabetes
* diagnosed with Type 2 diabetes and require insulin
* ≥ 10% weight loss in last six months
* enrolled in a weight loss management program
* enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation
* taking medications that affect weight loss or weight gain
* other physical or medical restrictions that would preclude following the minimum recommendations for moderate physical activity and healthy eati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1: Differences in Change in Weight between Groups - Body Weight (kg)
Timeframe: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
2
Differences in Change in Weight between Groups - waist circumference (cm)
Timeframe: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
3
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake
Timeframe: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
4
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity
Timeframe: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
5
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure
Timeframe: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months
6
Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids