Overview

This trial has been completed.

Condition overweight and obesity
Treatments experimental: web-based only (wo) weight intervention, experimental: wo plus peer-led discussion board (wd), experimental: wo & professional email counseling (we)
Sponsor University of Nebraska
Collaborator National Institute of Nursing Research (NINR)
Start date May 2011
End date December 2014
Trial size 301 participants
Trial identifier NCT01307644, 1R01NR010589-01A2, 237-10-FB

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Experimental)
A comprehensive lifestyle modification intervention for healthy eating and activity delivered by web only to facilitate Phase I weight loss (weekly messages baseline to 6 months), Phase 2 guided weight loss and weight maintenance (bi-weekly hot topics news, 6-18 months) and Phase 3 self-managed weight maintenance (6 monthly and 3 bi-monthly new content, 18-30 months).
experimental: web-based only (wo) weight intervention
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.
(Experimental)
Includes WO intervention, including all 3 Phases for weight loss and weight maintenance, supplemented with peer-lead discussion board. A peer leader will facilitate the asynchronous discussion group. The primary purpose of this group is to provide support, increase self-efficacy (role modeling by successful women and leader) and discuss progress toward goals.
experimental: web-based only (wo) weight intervention
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.
experimental: wo plus peer-led discussion board (wd)
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.
(Experimental)
Includes WO intervention, including all 3 Phases for weight loss and weight maintenance, supplemented with professional email-counseling by experienced counselor who will review women's web-logs of eating, activity, weight and goal-setting on web-site and send e-mail feedback.
experimental: web-based only (wo) weight intervention
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.
experimental: wo & professional email counseling (we)
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.

Primary Outcomes

Measure
Aim 1: Differences in Change in Weight between Groups - Body Weight (kg)
time frame: Differences in change in body weight (kg) between groups by phases [(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: Differences in change in waist circumference (cm) between groups by phases [(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 - Kcal intake
time frame: Differences in change in kcal intake daily between groups by phases (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: Differences in change in weekly minutes of moderate or greater intensity physical activity between groups by phase (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: Differences in change in weekly minutes of systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) between groups by phases (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: Differences in change in total cholesterol (ml/dL), HDL (ml/dL), LDL (ml/dL), and tryglycerides (ml/dL) between groups by phases (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)

Secondary Outcomes

Measure
Aim 1: Differences in Change in attaining Criterion-based Weight loss targets between Groups
time frame: Differences in Change in Proportions of Women attaining at least 5% and/or 10% or greater body weight loss between groups by phases (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: Differences in Change of Proportions of Women achieving 20-35% daily calories from fat between groups by phases (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
time frame: Differences in Change of Proportions of Women achieving at least 150 minutes weekly moderate or greater intensity activity between groups by phases (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)

Eligibility Criteria

Female participants from 40 years up to 69 years old.

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 eating.

Additional Information

Official title Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women
Principal investigator Carol H. Pullen, EdD, RN
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Nebraska.