Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03205007 |
| Other study ID # |
133-AAB8352 |
| Secondary ID |
2017-0188A540300 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
May 15, 2018 |
Study information
| Verified date |
January 2019 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
