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Clinical Trials/NCT04991844
NCT04991844CompletedNot Applicable

Healthy Eating for Successful Living in Older Adults™ Community Education Program

Health and Healing Research Education and Service, Inc.2 sites in 1 country292 target enrollmentStarted: July 26, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
292
Locations
2
Primary Endpoint
Change from baseline dietary fiber intake at 6 months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change from baseline polyunsaturated fat intake at 6 months(6 months post-intervention)
  • Change from baseline cholesterol intake at 6 months(6 months post-intervention)
  • Change from baseline omega-6 fat intake at 6 months(6 months post-intervention)
  • Change from baseline vitamin D intake at 6 months(6 months post-intervention)
  • Change from baseline magnesium intake at 6 months(6 months post-intervention)
  • Change from baseline nut and seed intake at 6 months(6 months post-intervention)
  • Change from baseline quality of life measure at 6 months(6 months post-intervention)
  • Change from baseline trans fat intake at 6 months(6 months post-intervention)
  • Change from baseline omega-3 fat intake at 6 months(6 months post-intervention)
  • Change from baseline vitamin B12 intake at 6 months(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(6 months post-intervention)
  • Change from baseline saturated 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 folate intake at 6 months(6 months post-intervention)
  • Change from baseline potassium intake at 6 months(6 months post-intervention)
  • Change from baseline vitamin B6 intake at 6 months(6 months post-intervention)
  • Change from baseline legume intake at 6 months(6 months post-intervention)
  • Change from baseline whole grain intake at 6 months(6 months post-intervention)
  • Change from baseline physical activity at 6 months(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(6 months post-intervention)
  • Change in response to the sentence: "I play an active role in my health care and well-being."(6 months post-intervention)
  • Change from baseline calcium intake at 6 months(6 months post-intervention)
  • Change from baseline fruit intake at 6 months(6 months post-intervention)
  • Change from baseline vegetable intake at 6 months(6 months post-intervention)
  • Change from baseline Body mass index at 6 months (BMI, Kg/m2)(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(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(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(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(6 months post-intervention)

Investigators

Sponsor
Health and Healing Research Education and Service, Inc.
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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