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Healthy Eating for Successful Living in Older Adults Program (HE) Study (HES)

Primary Purpose

Chronic Diseases, Multiple

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group
Sponsored by
Health and Healing Research Education and Service, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Diseases, Multiple

Eligibility Criteria

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

Inclusion Criteria:

  • willingness to participate and complete all study activities following randomization into the intervention or control group.
  • English-speaking.
  • interested and able to participate.

Exclusion Criteria:

  • None

Sites / Locations

  • Health and Healing Research Education and Service, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention Group

Arm Description

The control group did not receive any intervention, but met at three timepoints to complete study questionnaires and provide anthropometric measurements,

This group received the study intervention protocol.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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.
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).
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).
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).
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).
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.
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.
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.

Full Information

First Posted
July 2, 2021
Last Updated
July 27, 2021
Sponsor
Health and Healing Research Education and Service, Inc.
Collaborators
Georgetown University
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1. Study Identification

Unique Protocol Identification Number
NCT04991844
Brief Title
Healthy Eating for Successful Living in Older Adults Program (HE) Study
Acronym
HES
Official Title
Healthy Eating for Successful Living in Older Adults™ Community Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health and Healing Research Education and Service, Inc.
Collaborators
Georgetown University

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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group did not receive any intervention, but met at three timepoints to complete study questionnaires and provide anthropometric measurements,
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
This group received the study intervention protocol.
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline dietary fiber intake at 6 months
Description
Change from baseline dietary fiber intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Change from baseline saturated fat intake at 6 months
Description
Change from baseline dietary saturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline polyunsaturated fat intake at 6 months
Description
Change from baseline dietary polyunsaturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline monounsaturated fat intake at 6 months
Description
Change from baseline dietary monounsaturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ.
Time Frame
6 months post-intervention
Title
Change from baseline trans fat intake at 6 months
Description
Change from baseline dietary trans fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline cholesterol intake at 6 months
Description
Change from baseline dietary cholesterol intake (mean intake in mg/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline omega-3 fat intake at 6 months
Description
Change from baseline dietary omega-3 fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline omega-6 fat intake at 6 months
Description
Change from baseline dietary omega-6 fat intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline calcium intake at 6 months
Description
Change from baseline dietary calcium intake (mean intake in mg/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline vitamin D intake at 6 months
Description
Change from baseline dietary vitamin D intake (mean intake in IU/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline folate intake at 6 months
Description
Change from baseline folate intake (mean intake in mcg/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline potassium intake at 6 months
Description
Change from baseline potassium intake (mean intake in mg/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline magnesium intake at 6 months
Description
Change from baseline magnesium intake (mean intake in mg/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline vitamin B6 intake at 6 months
Description
Change from baseline vitamin B6 intake (mean intake in mg/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline vitamin B12 intake at 6 months
Description
Change from baseline vitamin B12 intake (mean intake in mcg/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline fruit intake at 6 months
Description
Change from baseline fruit intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline vegetable intake at 6 months
Description
Change from baseline vegetable intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline legume intake at 6 months
Description
Change from baseline legume intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline whole grain intake at 6 months
Description
Change from baseline whole grain intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline nut and seed intake at 6 months
Description
Change from baseline nut and seed intake (mean intake in g/day) at 6 months using the Willett FFQ
Time Frame
6 months post-intervention
Title
Change from baseline physical activity at 6 months
Description
Change from baseline physical activity (metabolic equivalent task (MET)-hours per week ) at 6 months using the Harvard Physical Activity Questionnaire.
Time Frame
6 months post-intervention
Title
Change from baseline Body mass index at 6 months (BMI, Kg/m2)
Description
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
Time Frame
6 months post-intervention
Title
Change from baseline quality of life measure at 6 months
Description
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.
Time Frame
6 months post-intervention
Title
Change in response to the question: "do you make food choices that are healthy for your bones?" from baseline at 6 months
Description
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).
Time Frame
6 months post-intervention
Title
Change in response to the question: "do you make food choices that are healthy for your heart?" from baseline at 6 months
Description
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).
Time Frame
6 months post-intervention
Title
Change in response to the question: "do you read nutrition labels when shopping or planning for meals?" from baseline at 6 months
Description
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).
Time Frame
6 months post-intervention
Title
Change in response to the question:"do you use MyPlateTM tools to help make food choices?" from baseline at 6 months
Description
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).
Time Frame
6 months post-intervention
Title
Change in response to the question: "How confident are you that you can manage most of your health problems?" from baseline at 6 months
Description
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.
Time Frame
6 months post-intervention
Title
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
Description
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.
Time Frame
6 months post-intervention
Title
Change in response to the sentence: "I play an active role in my health care and well-being."
Description
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.
Time Frame
6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: willingness to participate and complete all study activities following randomization into the intervention or control group. English-speaking. interested and able to participate. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junaidah Barnett, PhD, MCH(N)
Organizational Affiliation
Health and Healing Research Education and Service, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Healing Research Education and Service, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no such plans.
Citations:
PubMed Identifier
36187849
Citation
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.
Results Reference
derived

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Healthy Eating for Successful Living in Older Adults Program (HE) Study

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