Skip to main content
OpenTrials
Completed

NCT Number: NCT01307644

Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women, Also Known as Women Weigh-in for Wellness

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Web-based only (WO) weight intervention

Behavioral

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)

Behavioral

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: WO & professional email counseling (WE)

Behavioral

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

  1. 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)].

  2. 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)

  3. 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)]

  4. 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

  5. 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

  6. 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

  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 1: Differences in Change in attaining Criterion-based Weight loss targets between Groups

  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 Healthy Eating between Groups

  3. Differences in Change in attaining Criterion-based Physical Activity 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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Mar 3, 2011
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.