Chronic Diseases, MultipleHESNCT04991844
Healthy Eating for Successful Living in Older Adults Program (HE) Study
A study testing Intervention Group in people with Chronic Diseases, Multiple, run by Health and Healing Research Education and Service, Inc. at 1 site in United States.
Trial summary
The Healthy Eating for Successful Living in Older Adults™ (HESL) is a six-week community nutrition and lifestyle education program designed specifically for the elderly (>60 years), to promote dietary and behavioral changes towards a healthy lifestyle. The intervention was evaluated using a randomized-controlled trial. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Diseases, Multiple
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 31 Jan 2020
- 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
- willingness to participate and complete all study activities following randomization into the intervention or control group.
- English-speaking.
- interested and able to participate.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Health and Healing Research Education and Service, Inc.
Boston, Massachusetts, 02131
About this study
Official title: Healthy Eating for Successful Living in Older Adults™ Community Education Program
The Healthy Eating for Successful Living in Older Adults™ (HESL) is a six-week community nutrition and lifestyle education program designed specifically for the elderly (>60 years), to promote dietary and behavioral changes towards a healthy lifestyle. The intervention was evaluated using a randomized-controlled trial.
Read the detailed description
The elderly are at a higher risk of various chronic diseases. The burden of various chronic diseases such as heart disease and osteoporosis can be reduced with change in dietary and other lifestyle behaviors. The Healthy Eating for Successful Living in Older Adults™ (HESL) provides elderly with needed knowledge on healthy food choices and lifestyle behaviors, and tools that support behavioral changes. The investigators aimed to evaluate this intervention program by determining, among others, the impact of the intervention on factors such as dietary intake of fiber, and other nutrients, as well as healthy behaviors and food choices, and quality of life at 6 months post-intervention, using a randomized-controlled trial. The intervention group was compared to the control group receiving no intervention to evaluate the effects of the six-week HESL intervention on our outcome measures of interest.
- Conditions
- Chronic Diseases, Multiple
- Being tested
- Intervention Group
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Intervention group participants met once a week, for 2.5 hours, over a period of six weeks for the HES workshops. The HES workshops followed a scripted curriculum that incorporated information from the USDA's MyPlateTM, and the USDA 2015-2020 dietary guidelines. Participants were also taught goal-setting, problem-solving through brainstorming, group support, self-assessment and management of dietary and physical activity patterns.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group did not receive any intervention, but met at three timepoints to complete study questionnaires and provide anthropometric measurements, |
| Intervention Group | Experimental | This group received the study intervention protocol. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline dietary fiber intake at 6 months
Change from baseline dietary fiber intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Secondary outcomes (29)
Change from baseline saturated fat intake at 6 months
Change from baseline dietary saturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline polyunsaturated fat intake at 6 months
Change from baseline dietary polyunsaturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline monounsaturated fat intake at 6 months
Change from baseline dietary monounsaturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ.
Measured: 6 months post-intervention
Change from baseline trans fat intake at 6 months
Change from baseline dietary trans fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline cholesterol intake at 6 months
Change from baseline dietary cholesterol intake (mean intake in mg/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline omega-3 fat intake at 6 months
Change from baseline dietary omega-3 fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline omega-6 fat intake at 6 months
Change from baseline dietary omega-6 fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline calcium intake at 6 months
Change from baseline dietary calcium intake (mean intake in mg/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline vitamin D intake at 6 months
Change from baseline dietary vitamin D intake (mean intake in IU/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline folate intake at 6 months
Change from baseline folate intake (mean intake in mcg/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline potassium intake at 6 months
Change from baseline potassium intake (mean intake in mg/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline magnesium intake at 6 months
Change from baseline magnesium intake (mean intake in mg/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline vitamin B6 intake at 6 months
Change from baseline vitamin B6 intake (mean intake in mg/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline vitamin B12 intake at 6 months
Change from baseline vitamin B12 intake (mean intake in mcg/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline fruit intake at 6 months
Change from baseline fruit intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline vegetable intake at 6 months
Change from baseline vegetable intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline legume intake at 6 months
Change from baseline legume intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline whole grain intake at 6 months
Change from baseline whole grain intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline nut and seed intake at 6 months
Change from baseline nut and seed intake (mean intake in g/day) at 6 months using the Willett FFQ
Measured: 6 months post-intervention
Change from baseline physical activity at 6 months
Change from baseline physical activity (metabolic equivalent task (MET)-hours per week ) at 6 months using the Harvard Physical Activity Questionnaire.
Measured: 6 months post-intervention
Change from baseline Body mass index at 6 months (BMI, Kg/m2)
Change from baseline Body mass index (calculated from: weight in kilograms, and height in meters; weight and height will be combined to report BMI, Kg/m2) at 6 months
Measured: 6 months post-intervention
Change from baseline quality of life measure at 6 months
Change from baseline quality of life measure at 6 months using the Euro-QoL-5D-5L questionnaire; Participants were asked to provide a rating of their own health on a scale of 0-100, where 0 means "death" and 100 means "the best health.
Measured: 6 months post-intervention
Change in response to the question: "do you make food choices that are healthy for your bones?" from baseline at 6 months
Change in response (in percentage points) to the above question at 6 months; questions were originally in a Likert scale from always to never with five categories. We converted responses into dummy variables (with 1=always, most of the time, or sometimes; and 0 =rarely and never).
Measured: 6 months post-intervention
Change in response to the question: "do you make food choices that are healthy for your heart?" from baseline at 6 months
Change in response (in percentage points) to the above question at 6 months; questions were originally in a Likert scale from always to never with five categories. We converted responses into dummy variables (with 1=always, most of the time, or sometimes; and 0 =rarely and never).
Measured: 6 months post-intervention
Change in response to the question: "do you read nutrition labels when shopping or planning for meals?" from baseline at 6 months
Change in response (in percentage points) to the above question at 6 months; questions were originally in a Likert scale from always to never with five categories. We converted responses into dummy variables (with 1=always, most of the time, or sometimes; and 0 =rarely and never).
Measured: 6 months post-intervention
Change in response to the question:"do you use MyPlateTM tools to help make food choices?" from baseline at 6 months
Change in response (in percentage points) to the above question at 6 months; questions were originally in a Likert scale from always to never with five categories. We converted responses into dummy variables (with 1=always, most of the time, or sometimes; and 0 =rarely and never).
Measured: 6 months post-intervention
Change in response to the question: "How confident are you that you can manage most of your health problems?" from baseline at 6 months
Change in response (in percentage points) to the above question at 6 months; questions were originally on a scale of 0-10, with 10 being most confident. These ratings were coded as 1 if they were 6 and above, and 0 if 5 or below.
Measured: 6 months post-intervention
Change in response to the question: "How understandable and useful is the information that your doctor or nurses have given you about your health problems or concerns?" from baseline at 6 months
Change in response (in percentage points) to the above question at 6 months; questions were originally on a scale of 0-10, with 10 being most understandable/useful. These ratings were coded as 1 if they were 6 and above, and 0 if 5 or below.
Measured: 6 months post-intervention
Change in response to the sentence: "I play an active role in my health care and well-being."
Change in response (in percentage points) to the above question at 6 months; questions were originally on a scale of 0-10, with 10 being most active. These ratings were coded as 1 if they were 6 and above, and 0 if 5 or below.
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start26 Jul 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Diseases, MultipleStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health and Healing Research Education and Service, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Sponsor
- Investigators
- Junaidah Barnett, PhD, MCH(N), Principal investigator, Health and Healing Research Education and Service, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991844
- Sponsor's protocol ID
- 120180167
- Acronym
- HES
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no such plans.
Publications
Barnett JB, Zeng W. Healthy Eating for Successful Living in Older Adults community education program-evaluation of lifestyle behaviors: A randomized controlled trial. Front Aging. 2022 Sep 6;3:960986. doi: 10.3389/fragi.2022.960986. eCollection 2022.
PubMed 36187849
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating for Successful Living in Older Adults™ Community Education Program
- ClinicalTrials.gov ID
- NCT04991844
- Acronym / sponsor ID
- HES / 120180167
- Conditions
- Chronic Diseases, Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Health and Healing Research Education and Service, Inc.University, hospital or other
- Collaborators
- Georgetown University
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 5 Aug 2021 (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.
The Healthy Eating for Successful Living in Older Adults™ (HESL) is a six-week community nutrition and lifestyle education program designed specifically for the elderly (>60 years), to promote dietary and behavioral changes towards a healthy lifestyle. The intervention was evaluated using a randomized-controlled trial.
Detailed description
The elderly are at a higher risk of various chronic diseases. The burden of various chronic diseases such as heart disease and osteoporosis can be reduced with change in dietary and other lifestyle behaviors. The Healthy Eating for Successful Living in Older Adults™ (HESL) provides elderly with needed knowledge on healthy food choices and lifestyle behaviors, and tools that support behavioral changes. The investigators aimed to evaluate this intervention program by determining, among others, the impact of the intervention on factors such as dietary intake of fiber, and other nutrients, as well as healthy behaviors and food choices, and quality of life at 6 months post-intervention, using a randomized-controlled trial. The intervention group was compared to the control group receiving no intervention to evaluate the effects of the six-week HESL intervention on our outcome measures of interest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group did not receive any intervention, but met at three timepoints to complete study questionnaires and provide anthropometric measurements, |
| Intervention Group | Experimental | Behavioral: Intervention GroupThis group received the study intervention protocol. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- willingness to participate and complete all study activities following randomization into the intervention or control group.
- English-speaking.
- interested and able to participate.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Intervention GroupIntervention group participants met once a week, for 2.5 hours, over a period of six weeks for the HES workshops. The HES workshops followed a scripted curriculum that incorporated information from the USDA's MyPlateTM, and the USDA 2015-2020 dietary guidelines. Participants were also taught goal-setting, problem-solving through brainstorming, group support, self-assessment and management of dietary and physical activity patterns. | Behavioural | Intervention Group |
Primary outcome
Change from baseline dietary fiber intake at 6 months
Time frame: 6 months post-intervention
Change from baseline dietary fiber intake (mean intake in g/day) at 6 months using the Willett FFQ
29 secondary outcomes
Change from baseline saturated fat intake at 6 months
Time frame: 6 months post-intervention
Change from baseline polyunsaturated fat intake at 6 months
Time frame: 6 months post-intervention
Change from baseline monounsaturated fat intake at 6 months
Time frame: 6 months post-intervention
Change from baseline trans fat intake at 6 months
Time frame: 6 months post-intervention
Change from baseline cholesterol intake at 6 months
Time frame: 6 months post-intervention
Change from baseline omega-3 fat intake at 6 months
Time frame: 6 months post-intervention
Change from baseline omega-6 fat intake at 6 months
Time frame: 6 months post-intervention
Change from baseline calcium intake at 6 months
Time frame: 6 months post-intervention
Change from baseline vitamin D intake at 6 months
Time frame: 6 months post-intervention
Change from baseline folate intake at 6 months
Time frame: 6 months post-intervention
Change from baseline potassium intake at 6 months
Time frame: 6 months post-intervention
Change from baseline magnesium intake at 6 months
Time frame: 6 months post-intervention
Change from baseline vitamin B6 intake at 6 months
Time frame: 6 months post-intervention
Change from baseline vitamin B12 intake at 6 months
Time frame: 6 months post-intervention
Change from baseline fruit intake at 6 months
Time frame: 6 months post-intervention
Change from baseline vegetable intake at 6 months
Time frame: 6 months post-intervention
Change from baseline legume intake at 6 months
Time frame: 6 months post-intervention
Change from baseline whole grain intake at 6 months
Time frame: 6 months post-intervention
Change from baseline nut and seed intake at 6 months
Time frame: 6 months post-intervention
Change from baseline physical activity at 6 months
Time frame: 6 months post-intervention
Change from baseline Body mass index at 6 months (BMI, Kg/m2)
Time frame: 6 months post-intervention
Change from baseline quality of life measure at 6 months
Time frame: 6 months post-intervention
Change in response to the question: "do you make food choices that are healthy for your bones?" from baseline at 6 months
Time frame: 6 months post-intervention
Change in response to the question: "do you make food choices that are healthy for your heart?" from baseline at 6 months
Time frame: 6 months post-intervention
Change in response to the question: "do you read nutrition labels when shopping or planning for meals?" from baseline at 6 months
Time frame: 6 months post-intervention
Change in response to the question:"do you use MyPlateTM tools to help make food choices?" from baseline at 6 months
Time frame: 6 months post-intervention
Change in response to the question: "How confident are you that you can manage most of your health problems?" from baseline at 6 months
Time frame: 6 months post-intervention
Change in response to the question: "How understandable and useful is the information that your doctor or nurses have given you about your health problems or concerns?" from baseline at 6 months
Time frame: 6 months post-intervention
Change in response to the sentence: "I play an active role in my health care and well-being."
Time frame: 6 months post-intervention
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 5 Aug 2021.
- Derived from this study: PubMed 36187849Barnett JB, Zeng W. Healthy Eating for Successful Living in Older Adults community education program-evaluation of lifestyle behaviors: A randomized controlled trial. Front Aging. 2022 Sep 6;3:960986. doi: 10.3389/fragi.2022.960986. eCollection 2022.
- Individual participant dataSharing planned: No. There is currently no such plans.
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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.
Junaidah Barnett, PhD, MCH(N) principal investigator
Health and Healing Research Education and Service, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Chronic Diseases, Multiple, run by Health and Healing Research Education and Service, Inc. 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 3 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 5 Aug 2021. 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?
Change from baseline dietary fiber intake at 6 months (time frame: 6 months post-intervention). 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 NCT04991844, which also lists 1 linked publication.
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 5 Aug 2021.