NCT04991844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
Last Updated

August 5, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

July 2, 2021

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months post-intervention

Secondary Outcomes (29)

  • Change from baseline saturated fat intake at 6 months

    6 months post-intervention

  • Change from baseline polyunsaturated fat intake at 6 months

    6 months post-intervention

  • Change from baseline monounsaturated fat intake at 6 months

    6 months post-intervention

  • Change from baseline trans fat intake at 6 months

    6 months post-intervention

  • Change from baseline cholesterol intake at 6 months

    6 months post-intervention

  • +24 more secondary outcomes

Study Arms (2)

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.

Behavioral: Intervention Group

Interventions

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.

Intervention Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health and Healing Research Education and Service, Inc.

Boston, Massachusetts, 02131, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Junaidah Barnett, PhD, MCH(N)

    Health and Healing Research Education and Service, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

August 5, 2021

Study Start

July 26, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

August 5, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

There is currently no such plans.

Locations