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Overweight and ObesityNCT01307644

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

A study testing Experimental: Web-based only (WO) weight intervention, Experimental: WO plus peer-led discussion board (WD) and Experimental: WO & professional email counseling (WE) in people with Overweight and Obesity, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 69 years, women only
Conditions the study is for
Overweight and Obesity
What is being tested?
Experimental: Web-based only (WO) weight intervention, Experimental: WO plus peer-led discussion board (WD) and Experimental: WO & professional email counseling (WE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
1 siteUnited States
Study dates
1 May 2011to 1 Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 69 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Experimental: Web-based only (WO) weight intervention, Experimental: WO plus peer-led discussion board (WD), Experimental: WO & professional email counseling (WE)
Keywords
Overweight, Obesity, Rural Health, Weight Loss, Weight Maintenance, Rural Middle Aged and Older Women, Web Intervention Weight Loss, Class I, II, & III obese (BMI 28 to 45)
Medical subject headings
Overweight, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Web-based only (WO) weight interventionBehavioural

    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)Behavioural

    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)Behavioural

    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.

Study groups in NCT01307644
Study groupRoleWhat they receive
Web-based only (WO) weight interventionExperimentalA 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).
Receives: Behavioral: Experimental: Web-based only (WO) weight intervention
WO & peer-led discussion board (WD)ExperimentalIncludes 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.
Receives: Behavioral: Experimental: Web-based only (WO) weight intervention; Behavioral: Experimental: WO plus peer-led discussion board (WD)
WO & professional email counseling (WE)ExperimentalIncludes 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.
Receives: Behavioral: Experimental: Web-based only (WO) weight intervention; Behavioral: Experimental: WO & professional email counseling (WE)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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)].

    Measured: 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)

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

    Measured: 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

    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)]

    Measured: 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

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

    Measured: 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

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

    Measured: 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

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

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

Secondary outcomes (3)

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

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

    Measured: 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 attaining Criterion-based Healthy Eating between Groups

    Aim 2: Differences in Change in attaining Criterion-based Healthy Eating between Groups

    Measured: 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 attaining Criterion-based Physical Activity between Groups

    Aim 2: Differences in Change in attaining Criterion-based Physical Activity between Groups

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study start1 May 2011
  3. Primary completion1 Dec 2014
  4. Study completion1 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307644
Sponsor's protocol ID
0237-10-FB
Other IDs
1R01NR010589-01A2
Status last verified
Aug 2023
First submitted
1 Mar 2011
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hageman PA, Mroz JE, Yoerger MA, Pullen CH. Weight loss is associated with improved quality of life among rural women completers of a web-based lifestyle intervention. PLoS One. 2019 Nov 19;14(11):e0225446. doi: 10.1371/journal.pone.0225446. eCollection 2019.

    PubMed 31743365

  • Hageman PA, Mroz JE, Yoerger MA, Pullen CH. User Engagement Associated with Web-Intervention Features to Attain Clinically Meaningful Weight Loss and Weight Maintenance in Rural Women. J Obes. 2019 Mar 3;2019:7932750. doi: 10.1155/2019/7932750. eCollection 2019.

    PubMed 30944736

  • Hageman PA, Pullen CH, Yoerger M. Physical Function and Health-Related Quality of Life in Overweight and Obese Rural Women Who Meet Physical Activity Recommendations. J Aging Phys Act. 2018 Jul 1;26(3):438-444. doi: 10.1123/japa.2017-0117. Epub 2018 Jun 13.

    PubMed 28952857

  • Hageman PA, Pullen CH, Hertzog M, Pozehl B, Eisenhauer C, Boeckner LS. Web-Based Interventions Alone or Supplemented with Peer-Led Support or Professional Email Counseling for Weight Loss and Weight Maintenance in Women from Rural Communities: Results of a Clinical Trial. J Obes. 2017;2017:1602627. doi: 10.1155/2017/1602627. Epub 2017 Apr 5.

    PubMed 28480078

  • Shade MY, Berger AM, Dizona PJ, Pozehl BJ, Pullen CH. Sleep and health-related factors in overweight and obese rural women in a randomized controlled trial. J Behav Med. 2016 Jun;39(3):386-97. doi: 10.1007/s10865-015-9701-y. Epub 2015 Dec 11.

    PubMed 26661065

  • Hageman PA, Pullen CH, Hertzog M, Boeckner LS, Walker SN. Web-based interventions for weight loss and weight maintenance among rural midlife and older women: protocol for a randomized controlled trial. BMC Public Health. 2011 Jun 30;11:521. doi: 10.1186/1471-2458-11-521.

    PubMed 21718512

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Web-based only (WO) weight intervention, Experimental: WO plus peer-led discussion board (WD) and Experimental: WO & professional email counseling (WE) in people with Overweight and Obesity, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01307644, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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