Nutrition Disorders in Old AgeBBHLNCT03205007
Adaptation of a Health Promotion Nutrition Program for Older Adults
A study testing Health promotion nutrition program in people with Nutrition Disorders in Old Age, run by University of Wisconsin, Madison at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders in Old Age
- What is being tested?
- Health promotion nutrition program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2017to 15 May 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Independent
Who cannot join
- Kidney Disease -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin-Madison
Madison, Wisconsin, 53705
University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: Adaptation of a Health Promotion Nutrition Program for Older Adults Entitled:Beneficial Bites for Healthy Living
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.
Read the 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.
- Conditions
- Nutrition Disorders in Old Age
- Being tested
- Health promotion nutrition program
- Keywords
- Health Promotion, Nutrition, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion nutrition programBehavioural
Health promotion nutrition program
| Study group | Role | What they receive |
|---|---|---|
| Health promotion nutrition program | Experimental | Health promotion nutrition program Receives: Behavioral: Health promotion nutrition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Behavior
Block FFQ, Metabolomics
Measured: 8 weeks
Secondary outcomes (1)
Dietary Behavior
Block FFQ, Metabolomics
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Jun 2017
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Disorders in Old AgeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-Post changes in dietary behavior
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall Gretebeck, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205007
- Sponsor's protocol ID
- 133-AAB8352
- Other IDs
- 2017-0188, A540300, NUR\FACILITIES OPRTN
- Acronym
- BBHL
- Status last verified
- Jan 2019
- First submitted
- 28 Jun 2017
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Health Promotion Nutrition Program for Older Adults Entitled:Beneficial Bites for Healthy Living
- ClinicalTrials.gov ID
- NCT03205007
- Acronym / sponsor ID
- BBHL / 133-AAB8352
- Conditions
- Nutrition Disorders in Old Age
- Keywords
- Health Promotion, Nutrition, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-Post changes in dietary behavior
| Arm | Type | Receives |
|---|---|---|
| Health promotion nutrition program | Experimental | Behavioral: Health promotion nutrition programHealth promotion nutrition program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Independent
Key exclusion criteria (1 listed)
- Kidney Disease -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health promotion nutrition programHealth promotion nutrition program | Behavioural | Health promotion nutrition program |
Primary outcome
Dietary Behavior
Time frame: 8 weeks
Block FFQ, Metabolomics
1 secondary outcome
Dietary Behavior
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall Gretebeck, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion nutrition program in people with Nutrition Disorders in Old Age, run by University of Wisconsin, Madison at 2 sites 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 1 inclusion and 1 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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Dietary Behavior (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2019.