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Clinical Trials/NCT05804019
NCT05804019CompletedNot Applicable

Interventions Focusing on Nutrition and Physical Activities for Overweight and Obese Older Adults in Nursing Homes "IFEBO"

University College Absalon12 sites in 1 country93 target enrollmentStarted: March 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
93
Locations
12
Primary Endpoint
Hand Grip Strength (HGS)

Study Overview

Brief Summary

This cluster randomized trial aims to test nutritional and physical activity interventions in older adults in nursing homes. The overall research question are:

o What are the effects of nutritional and physical activity interventions on muscle function and quality of life in older adults with overweight and obesity? Participants' data on body composition, physical function, and diseases will be collected. Furthermore, participants will be interviewed for a questionnaire on quality of life and nutritional intake.

Researchers will compare three intervention nursing homes with three control nursing homes to see if nutrition and physical interventions have on physical function and quality of life.

Detailed Description

Background: The aging population is increasing both globally and nationally in Denmark. Concurrent with the generally rapidly increasing incidence of being overweight, a large number of older people risk facing several health problems associated with being overweight and obesity (Ow/O). Aging related to malnutrition or undernutrition has received a lot of attention. However, overnutrition described as Ow/O is also classified as a nutritional disorder or a nutrition-related condition, in the same term as malnutrition.

Today, all older adults in Danish nursing homes are offered an enriched diet type for malnourished older adults, focused on energy-dense snacks and a high-fat percentage. This is not necessarily an appropriate diet, but it is unknown which nutritional interventions are effective in maintaining/ improving physical functioning, independence, and quality of life. One of the concerns is that many older adults with Ow/O may have a loss of muscle mass, which can worsen with weight loss if this is not taken into account in the nutritional intervention. There is therefore a clear need to develop targeted interventions for older adults with Ow/O that can maintain or improve physical functioning and quality of life.

However, a literature review of interventions within the last 10 years shows that none of the interventions are aimed at healthy older adults ≥ 65 years with a BMI≥ 25kg/m2 and good physical functioning. Instead, interventions targeted older adults with Ow/O with either low physical functioning or chronic diseases. These interventions show that older adults can lose weight, but without significant positive effects on functioning and quality of life. The interventions in the studies contain complex nutrition and exercise interventions, and the differences in the intervention descriptions and target groups make it difficult to compare and point to safe and effective interventions. In addition, the studies show that there is no difference between whether the nutrition intervention applies to weight loss or weight maintenance interventions.

However, the above literature review has confirmed that there are older people with Ow/O, especially those with both low physical function and chronic disease, who may benefit from a nutritional intervention, which has led to a proposed approach. The characterization according to the screening model will be performed in sub-study 1 (a cross-sectional study) and adapted to be easy to use in a community health care setting.

In this trial, based on a descriptive pre-study, the project, in collaboration with the older adults, the care staff, and the project participants, developed and tested nutritional interventions that can improve muscle function and quality of life of the target group.

Study Design

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

Eligibility Criteria

Ages
60 Years to 110 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Living at the nursing homes in Odsherred City
  • Informed consent form signed after receiving oral and written information
  • Read, speak and understand Danish

Exclusion Criteria

  • Terminal ill

Outcomes

Primary Outcomes

Hand Grip Strength (HGS)

Time Frame: Baseline

Muscle function assessed by HGS in kilograms as a unit. To measure HGS, the Standard Operating Procedure (SOP) was followed using a "Jamar Smart Hand Dynamometer". Three measurements on each hand will be completed, when participants were sitting upright and with the arm at a 90-degree angle. The test was performed by the principal researcher and trained clinical dietician students.

Change in Hand Grip Strength (HGS)

Time Frame: 12 months follow-up

Muscle function assessed by HGS in kilograms as a unit. To measure HGS, the Standard Operating Procedure (SOP) was followed using a ¨"Jamar Smart Hand Dynamometer". Three measurements on each hand will be completed, when participants were sitting upright and with the arm at a 90-degree angle. The test was performed by the principal researcher and trained clinical dietician students.

Chair Stand Test (CST) - 30 Second

Time Frame: Baseline

Muscle function assessed by CST. The test requires the participant to stand up and sit down as many times as possible within 30 seconds according to Standard Operating Procedure (SOP). The participants are seated in a standard chair with their feet shoulder length apart and one foot in front of the other, doing as many stands as possible within 30 seconds. The unit is the number of full stands performed. Trained clinical dietician students and primary researcher will perform all tests

Change in Chair Stand Test (CST) - 30 Second

Time Frame: 12 months follow-up

Muscle function assessed by CST. The test requires the participant to stand up and sit down as many times as possible within 30 seconds according to Standard Operating Procedure (SOP). The participants are seated in a standard chair with their feet shoulder length apart and one foot in front of the other, doing as many stands as possible within 30 seconds. The unit is the number of full stands performed. Trained clinical dietician students and primary researcher will perform all tests

Secondary Outcomes

  • Quality of Life by Adult Social Care Outcomes Toolkit (ASCOT)(Baseline)
  • Change in Quality of Life by Adult Social Care Outcomes Toolkit (ASCOT)(12 months follow-up)
  • Weight in kilograms(Baseline)
  • Change in weight in kilograms(12 months follow-up)

Investigators

Sponsor
University College Absalon
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (12)

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