Nutritional and Physical Activities for Overweight and Obese Older Adults

NCT05804019 | Completed DMC

• 3 other identifiers: IFEBO1155-00001B2022-03 Tenna Christoffersen
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 6

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.

Conditions

Overweight, Obesity and Other Hyperalimentation

Keywords

Geriatric; Overnutrition; Physical function; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Hand Grip Strength (HGS)

  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.

  Baseline

• Change in Hand Grip Strength (HGS)

  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.

  6 months follow-up

• Change in Hand Grip Strength (HGS)

  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.

  12 months follow-up

• Chair Stand Test (CST) - 30 Second

  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

  Baseline

• Change in Chair Stand Test (CST) - 30 Second

  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

  6 months follow-up

• Change in Chair Stand Test (CST) - 30 Second

  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

  12 months follow-up

Secondary Outcomes (6)

• Quality of Life by Adult Social Care Outcomes Toolkit (ASCOT)

  Baseline

• Change in Quality of Life by Adult Social Care Outcomes Toolkit (ASCOT)

  6 months follow-up

• 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

  6 months follow-up

Other Outcomes (7)

• Height in meters

  Baseline

• Calf circumference

  Baseline

• Change in calf circumference

  6 months follow-up

Study Arms (2)

Usual Care Group (Control)

NO INTERVENTION

Approximately 100 participants will be included and cluster randomized by nursing home (n= 3) to either 12 months of nutritional and physical intervention or 12 months of usual care (control). Usual Care Group will receive the usual care at the control nursing homes (n=3)

Nutritional and Physical Intervention Group (Intervention Group)

EXPERIMENTAL

Approximately 100 participants will be included and cluster randomized by nursing home (n= 3) to either 12 months of nutritional and physical intervention or 12 months of usual care (control). The Nutritional and Physical Intervention Group will receive nutritional and physical interventions collaboratively defined by residents, relatives, care staff, and nursing home management during the PDSA workshops.

Behavioral: Nutritional and physical interventions

Interventions

Nutritional and physical interventions BEHAVIORAL

The intervention is developed with a focus on nutritional needs and physical activities. The Plan-Do-Study-Act (PDSA) model is used to redefine issues and relevant actions together with residents, relatives, care staff, and nursing home management. The intervention will be developed based on new knowledge from sub-study 1, previous studies, practical experiences, the participant's experiences and wishes as well as the staff's experiences and wishes. Together they will form an implementation catalog, from here, the intervention nursing homes can select a relevant number of components, which will be tested and implemented in practice. The implementation duration is 6 months and the PDSA model is repeated at two-month intervals to strengthen and qualify the intervention. The PDSA model is known to the city's staff in advance and is additionally used in connection to continuing education. The Usual Care Group will continue the usual care.

Nutritional and Physical Intervention Group (Intervention Group)

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Terminal ill

Sponsors & Collaborators

• University College Absalon: lead
• Odsherred, Denmark: collaborator
• University of Copenhagen: collaborator
• Herlev Hospital: collaborator

Study Sites (6)

Bobjerg Nursing Home

Asnæs, Region Sjælland, 4550, Denmark

Location

Grevinge Nusing Home

Grevinge, Region Sjælland, 4571, Denmark

Location

Solvognen Nursing home

Højby, Region Sjælland, 4573, Denmark

Location

Bakkegården Nursing home

Hørve, Region Sjælland, 4534, Denmark

Location

Grønnegården Nursing home

Nykøbing Sjælland, Region Sjælland, 4500, Denmark

Location

Præstevænget Nursing Home

Nykøbing Sjælland, Region Sjælland, 4500, Denmark

Location

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Related Links

• Reference 2
• Reference 3
• Reference 32
• Reference 33
• Reference 34

MeSH Terms

Conditions

Overweight; Obesity; Overnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margit AD Aaslyng, Ph.D.

  University College Absalon

  STUDY CHAIR

• Inge Tetens, Professor

  University of Copenhagen

  STUDY CHAIR

• Anne Marie Beck, Master

  Herlev and Gentofte University Hospital,Denmark

  STUDY CHAIR

• Anja W Dynesen, Ph.D.

  University College Absalon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arms (Nutritional and Physical Activity Intervention Group and Usual Care Group). Approximately 100 participants will be included and cluster randomized by the nursing home to either 6 months of nutritional and physical interventions or 6 months of usual care (control).

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: April 7, 2023
• Study Start: March 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)