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Adaptation of a Health Promotion Nutrition Program for Older Adults (BBHL)

Primary Purpose

Nutrition Disorders in Old Age

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health promotion nutrition program
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutrition Disorders in Old Age focused on measuring Health Promotion, Nutrition, Older Adults

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Independent

Exclusion Criteria:

Kidney Disease -

Sites / Locations

  • University of Wisconsin-Madison
  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health promotion nutrition program

Arm Description

Health promotion nutrition program

Outcomes

Primary Outcome Measures

Dietary Behavior
Block FFQ, Metabolomics

Secondary Outcome Measures

Dietary Behavior
Block FFQ, Metabolomics

Full Information

First Posted
June 28, 2017
Last Updated
December 23, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03205007
Brief Title
Adaptation of a Health Promotion Nutrition Program for Older Adults
Acronym
BBHL
Official Title
Adaptation of a Health Promotion Nutrition Program for Older Adults Entitled:Beneficial Bites for Healthy Living
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Our overarching goal is to prove the benefit of a behavior change intervention designed to help older people overcome barriers associated with risk for inadequate nutrition, so that they can improve their nutritional intake of fruits and vegetables, low fat dairy, whole grains, nuts, lean meats, poultry and fish.
Detailed Description
Our overarching goal is to prove the benefit of a behavior change intervention designed to help older people overcome barriers associated with risk for inadequate nutrition, so that they can improve their nutritional intake of fruits and vegetables, low fat dairy, whole grains, nuts, lean meats, poultry and fish. In this proposal, as a first step, we will build on the Beneficial Bites health promotion nutrition program (developed by Dietitians in northwestern Wisconsin), to produce "Beneficial Bites for a Healthy Life" (BBHL), which uses Social Cognitive Theory to change older adults' eating behaviors to minimize risks for inadequate nutrition for older adults. We will use a pre-post design to evaluate changes in dietary behavior 1 week and 6 months after the BBHL program. Our goal is to create a program that incorporates senior-specific nutrition information and recommendations as well as behavior change principles. There currently is no proven program that includes both of these components. This project is designed to provide data for a randomized trial for later testing so that it will eventually become eligible for future federal health promotion program funding (through Older Americans Act Title IIID funding) and thus be self-sustainable across Wisconsin and the rest of the nation. Significance: Inadequate nutrition in older adults has been described as a crisis in America, which leads to increased illness and disability. This crisis is rapidly increasing as baby boomers age. A recent study looking at nutritional intake of older adults living in Pennsylvania found that 56% were at risk of inadequate nutrition2. Barriers to good nutrition include restricted finances leading to diets dominated by sugars, refined starches, and fatty meats; poor dental health, or problems chewing or swallowing food limiting healthy food choices; limited mobility making it difficult to shop for healthy foods; and lack of education on which foods are more nutrient dense leading to poor food choices. We propose to create a theory-based behavior change program that will not only provide nutrition education, but also will help older adults learn and incorporate into daily life strategies to minimize or overcome these common barriers to good nutrition. Current nutrition education programs tend to target a specific disease such as diabetes, heart disease, or osteoporosis, which may not be suitable for a general audience. Alternatively, a number of programs combine diet and exercise, but many older adults may be uninterested or unable to participate in exercise. Existing programs tend to focus more on providing education than on behavior change. Finally, no existing programs contain a maintenance component after the initial program is delivered. Given the prevalence of inadequate nutrition, older adults should have access to proven nutrition behavior-change programs. The federal government recognizes this need, and through the Older Americans Act (OAA), provides funding to the states for programs that support healthy lifestyles and promote healthy behaviors. Beginning October 1, 2016, all health promotion programs using OAA Title IIID funds have to meet the following criteria: "Proven effective with an older adult population, using Experimental or Quasi-Experimental Design". Currently, there are no health promotion nutrition programs for older adults that meet these criteria. This creates a critical need for a behavior change nutrition program with proven effectiveness, which can be implemented in Wisconsin and nationally under OAA Title IIID funding. Design and Aims: Aim 1 To modify the BBHL program, based on Social Cognitive Theory to: 1) change older adults' eating behaviors to improve nutritional intake of fruits and vegetables, low fat dairy, whole grains, nuts, lean meats, poultry and fish, and 2) help older adults to successfully and sustainably utilize strategies to overcome barriers associated with risk of inadequate nutrition. To address Aim 1, the Beneficial Bites program will be modified to produce a program entitled Beneficial Bites for a Healthy Life (BBHL). Overview of BBHL: This program will include 8 weekly 1.5 hour sessions designed to address common risks for inadequate nutrition faced by older adults, and help participants succeed in following a healthier diet building on behavior change techniques. The 8 sessions will promote fruits and vegetables, low or no fat dairy, whole grains, healthy fats, legumes and nuts, and lean meats, fish, and poultry. Each session will include: 1) group discussions with brain-storming to identify barriers and strategies to overcome barriers to eating a healthy diet; 2) an activity such as tasting different foods or playing nutrition related games; 3) homework, such as keeping a food diary (self-monitoring), or selecting nutritional foods when shopping (self-efficacy); and 4) feedback on performance of outside activities. When the 8 week program ends, a 6 month home program will begin. The dietitian will continue to monitor the participants with monthly coaching telephone calls designed to enhance maintenance of BBHL behavior change principles. Dietitians from the Aging and Disability Resource Center of Barron, Rusk & Washburn Counties, Darby Simpson, Jennifer Jako, and Leslie Fijalkiewicz, will prepare content for the 8 sessions. They are experienced in delivering evidence based health promotion programing for older adults and understand their target audience. The investigators in Madison will develop theory-driven behavior change programing to integrate into the sessions. Co-investigator Kimberlee Gretebeck previously developed behavior change lessons incorporating Social Cognitive Theory for a proven program, Physical Activity for Seniors for Life (PALS), which is being disseminated through ADRCs in 8 counties in Wisconsin, in preparation for statewide dissemination. The behavior change techniques and strategies used successfully in PALS (goal setting, barrier identification/problem solving, self-monitoring, relapse prevention, etc.) will be modified to relate to following a healthy diet. The nutrition content will then be merged with the behavior change component. The merged sessions will then be sent back to the dietitians for review and comment. It is anticipated that 2-3 revisions will be needed. BBHL will then be offered with 10 participants at the Senior Center in Cameron Wisconsin. After participating in BBHL, we will conduct a focus group with participants and interviews with BBHL leaders to determine what content to keep or omit. Responses will be used to revise BBHL. BBHL will be revised prior to starting Aim 2. Aim 2 Evaluate the modified BBHL for effectiveness of change in nutrient intake and nutrition behavior by subjective and objective measurement 1 week and 6 months after program completion. We hypothesize that participants will show improvements in the intake of fruits and vegetables, low or no fat dairy, whole grains, healthy fats, legumes and nuts, and lean meats, fish, and poultry one week and 6 months after the program compared to baseline (before beginning BBHL). To address Aim 2, BBHL will be offered once at the Cumberland Senior Center and twice at the Rice Lake Senior Center. A total of 30 participants (10 per group times 3 groups) will be recruited by the dietitians and support staff from the ADRC of Barron, Rusk & Washburn Counties using the recruiting methods they use for other evidence based health promotion programs they provide. Eligibility criteria to participate includes no severe dietary restrictions (kidney disease), and the ability to make independent food choices and prepare meals (individuals being provided with meals will be excluded). Moderate dietary restrictions associated with chronic diseases such as diabetes can be accommodated within the program. Before BBHL begins, after completing the 8 sessions, and after completing the 6 month maintenance period with coaching phone calls, participants will complete validated standardized questionnaires on food intake and nutrition behavior. The knowledge we gain from this pilot work will benefit not only the ADRC of Barron, Rusk, and Washburn counties with whom we are collaborating but the entire Aging Network of Wisconsin. If this program is shown to be beneficial based on pre-post data, then we will apply for Federal funding to conduct a randomized, controlled trial to prove effectiveness. Ultimately, we hope to create a proven program to improve nutritional intake by older adults. Once proven, we will work with Wisconsin's Aging Network and the Wisconsin Institute for Healthy Aging, to disseminate the program across the state of Wisconsin and nationally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders in Old Age
Keywords
Health Promotion, Nutrition, Older Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-Post changes in dietary behavior
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health promotion nutrition program
Arm Type
Experimental
Arm Description
Health promotion nutrition program
Intervention Type
Behavioral
Intervention Name(s)
Health promotion nutrition program
Intervention Description
Health promotion nutrition program
Primary Outcome Measure Information:
Title
Dietary Behavior
Description
Block FFQ, Metabolomics
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dietary Behavior
Description
Block FFQ, Metabolomics
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Independent Exclusion Criteria: Kidney Disease -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Gretebeck, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptation of a Health Promotion Nutrition Program for Older Adults

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