University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
NCT Number: NCT01307644
This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.
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Notify Me40 year–69 year
Female
Interventional
Not applicable
Omaha, Nebraska, 68198, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The WO intervention included evidence-based lifestyle modification for healthy eating and activity, with self-monitoring and goal setting, and messages based on constructs from the Health Promotion Model across 3 phases. The intent of the phases was to deliver more intensive intervention during Phase 1, transitioning to less intensive intervention during phase 2, to providing support for self managed weight maintenance during Phase 3.
Includes WO intervention plus asynchronous discussion board managed by peer leader, whose identity is masked. The peer leader who posted theme-based messages, called primers, that were consistent with WO themes across phases.
Includes WO intervention plus professional email counseling provided by a registered dietitian whose identity is masked. The email counselor is responsible for reviewing eating, activity, weight logs, and goals on the web-site and send e-mail feedback, in addition to responding to email questions. The e-mail process will follow the 5A's Model for Behavioral Counseling (assess, advise, agree, assist, and arrange) that was adapted for this study.
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)].
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)
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)]
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
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
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
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 attaining Criterion-based Weight loss targets between Groups
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 attaining Criterion-based Healthy Eating between Groups
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 attaining Criterion-based Physical Activity between Groups
University of Nebraska
Other
Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women
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