Skip to main content
Clinical Trials/NCT01307644
NCT01307644
Completed
Not Applicable

Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women

University of Nebraska1 site in 1 country301 target enrollmentMay 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
University of Nebraska
Enrollment
301
Locations
1
Primary Endpoint
Differences in Change in Weight between Groups - waist circumference (cm)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.

Detailed Description

According to the National Institutes of Health, "obesity is one of the most daunting health challenges of the 21st century". Approximately 2/3 of all adults are overweight or obese. Efforts to abate the growing prevalence of obesity have not been successful. The Strategic Plan for NIH Obesity Research proposes preventing and treating obesity through lifestyle modification. The purpose of this study is to evaluate the effectiveness of a theory-based intervention framed within the Health Promotion Model (HPM) in facilitating weight loss and maintenance through promotion of healthy eating and physical activity among an underserved, vulnerable population of overweight or obese rural women aged 40-69. During these years, women experience increases in peri- and post-menopausal health risks that are magnified if they are overweight or obese. Weight loss will reduce risks and enhance functional status as they age. Maintenance of weight loss will be emphasized. The Internet offers a way to reach isolated rural women who have limited options for weight loss guidance. PUBLIC HEALTH RELEVANCE: Obesity is recognized as a major and growing public health problem. While many weight loss programs have been successful in the short term, they have not been successful in helping to maintain weight loss.

Registry
clinicaltrials.gov
Start Date
May 1, 2011
End Date
August 1, 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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 eating.

Outcomes

Primary Outcomes

Differences in Change in Weight between Groups - waist circumference (cm)

Time Frame: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months

Aim 1: Differences in Change in Weight between Groups - waist circumference (cm)

1: Differences in Change in Weight between Groups - Body Weight (kg)

Time Frame: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months

Aim 1: The primary aim of the study was to compare the effectiveness of web-based only (WO) intervention with web-based interventions supplemented with peer-led discussion support group (WD) or professional email counseling (WE) for achieving change in the primary outcome of body weight between groups across three phases \[Phase I guided weight loss (baseline to 6 months), Phase 2 continued guided weight loss and weight maintenance over 12 months (6 months and 18 months), Phase 3 self-directed weight maintenance over 12 months (18 months and 30 months)\].

Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake

Time Frame: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months

Aim 2: The secondary aim of the study was to compare the effectiveness of web-based only (WO) intervention with web-based interventions supplemented with peer-led discussion support group (WD) or professional email counseling (WE) for achieving change in primary outcomes of behavioral and biomarkers of healthy eating and activity between groups across three phases \[Phase I guided weight loss (baseline and 6 months), Phase 2 continued guided weight loss and weight maintenance over 12 months (6 months and 18 months), Phase 3 self-directed weight maintenance over 12 months (18 months and 30 months)\]

Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity

Time Frame: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months

Aim 2: Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity

Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure

Time Frame: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months

Aim 2: Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure

Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids

Time Frame: Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months

Aim 2: Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids

Secondary Outcomes

  • Differences in Change in attaining Criterion-based Weight loss targets between Groups(Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
  • Differences in Change in attaining Criterion-based Healthy Eating between Groups(Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
  • Differences in Change in attaining Criterion-based Physical Activity between Groups(Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)

Study Sites (1)

Loading locations...

Similar Trials