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

July 27, 2021 updated by: Health and Healing Research Education and Service, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
292

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Intervention Group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Health and Healing Research Education and Service, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Georgetown University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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