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

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

292

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Health and Healing Research Education and Service, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The control group did not receive any intervention, but met at three timepoints to complete study questionnaires and provide anthropometric measurements,
Experimental: Intervention Group
This group received the study intervention protocol.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline saturated fat intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary saturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline polyunsaturated fat intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary polyunsaturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline monounsaturated fat intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary monounsaturated fat intake (mean intake in g/day) at 6 months using the Willett FFQ.
6 months post-intervention
Change from baseline trans fat intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary trans fat intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline cholesterol intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary cholesterol intake (mean intake in mg/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline omega-3 fat intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary omega-3 fat intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline omega-6 fat intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary omega-6 fat intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline calcium intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary calcium intake (mean intake in mg/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline vitamin D intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline dietary vitamin D intake (mean intake in IU/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline folate intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline folate intake (mean intake in mcg/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline potassium intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline potassium intake (mean intake in mg/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline magnesium intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline magnesium intake (mean intake in mg/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline vitamin B6 intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline vitamin B6 intake (mean intake in mg/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline vitamin B12 intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline vitamin B12 intake (mean intake in mcg/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline fruit intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline fruit intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline vegetable intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline vegetable intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline legume intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline legume intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline whole grain intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline whole grain intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline nut and seed intake at 6 months
Time Frame: 6 months post-intervention
Change from baseline nut and seed intake (mean intake in g/day) at 6 months using the Willett FFQ
6 months post-intervention
Change from baseline physical activity at 6 months
Time Frame: 6 months post-intervention
Change from baseline physical activity (metabolic equivalent task (MET)-hours per week ) at 6 months using the Harvard Physical Activity Questionnaire.
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 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
6 months post-intervention
Change from baseline quality of life measure at 6 months
Time Frame: 6 months post-intervention
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.
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 (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).
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 (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).
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 (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).
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 (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).
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 (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.
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 (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.
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
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.
6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Junaidah Barnett, PhD, MCH(N), Health and Healing Research Education and Service, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2018

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 120180167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is currently no such plans.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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