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

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Experimental: Web-based only (WO) weight intervention

Experimental: WO plus peer-led discussion board (WD)

Experimental: WO & professional email counseling (WE)

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring 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)

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Web-based only (WO) weight intervention

WO & peer-led discussion board (WD)

WO & professional email counseling (WE)

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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)].

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

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

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)]

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

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

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

Secondary Outcome Measures

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

Differences in Change in attaining Criterion-based Healthy Eating between Groups

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

Differences in Change in attaining Criterion-based Physical Activity between Groups

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

Full Information

NCT ID

NCT01307644

First Posted

March 1, 2011

Last Updated

August 30, 2023

Sponsor

University of Nebraska

Collaborators

National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT01307644

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

May 1, 2011 (Actual)

Primary Completion Date

December 1, 2014 (Actual)

Study Completion Date

August 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

Collaborators

National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Web-based only (WO) weight intervention

Arm Type

Experimental

Arm Description

Arm Title

WO & peer-led discussion board (WD)

Arm Type

Experimental

Arm Description

Arm Title

WO & professional email counseling (WE)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Experimental: Web-based only (WO) weight intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Experimental: WO plus peer-led discussion board (WD)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Experimental: WO & professional email counseling (WE)

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

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

Title

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

Description

Time Frame

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Secondary Outcome Measure Information:

Title

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

Description

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

Title

Differences in Change in attaining Criterion-based Healthy Eating between Groups

Description

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

Title

Differences in Change in attaining Criterion-based Physical Activity between Groups

Description

Aim 2: 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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol H Pullen, EdD, RN

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31743365

Citation

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.

Results Reference

derived

PubMed Identifier

30944736

Citation

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.

Results Reference

derived

PubMed Identifier

28952857

Citation

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.

Results Reference

derived

PubMed Identifier

28480078

Citation

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.

Results Reference

derived

PubMed Identifier

26661065

Citation

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.

Results Reference

derived

PubMed Identifier

21718512

Citation

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.

Results Reference

derived

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

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