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Completed

NCT Number: NCT04991844

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

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.

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Key information

Conditions

Chronic Diseases, Multiple Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health and Healing Research Education and Service, Inc.

Boston, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

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 outcomes

  1. 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

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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.

  21. 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

  22. 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.

  23. 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).

  24. 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).

  25. 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).

  26. 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).

  27. 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.

  28. 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.

  29. 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.

Sponsors and collaborators

Lead sponsor

Health and Healing Research Education and Service, Inc.

Other

Collaborators

  • Georgetown University

Registry information

Official study title

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

Acronym: HES

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2021
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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