Older AdultsNCT05067036
Physical Activity, Appetite and Food Intake in Older Adults (PHYSISAT)
An observational study of Older Adults and Physical Activity, run by University of Reading at 1 site in United Kingdom.
Trial summary
This study aims to assess the effect of physical activity on food intake and appetite in older adults (≥ 65 years) and to investigate the relationship between older adults' eating behaviours, body composition and physical activity. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Physical Activity, Food Intake
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2020to 9 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Participants aged older than 65 years.
Who may be able to join
- Healthy, living independently and self-reported;
- Aged ≥ 65 years;
- Having the ability to understand the study procedures.
Who cannot join
- Being obese (BMI > 30 kg/m2);
- Smoking more than 10 cigarettes a day;
- Having a disease such as cardiovascular disease and other chronic diseases (diabetes, thyroid disorders, cancer, heart, lung and kidney disease;
- Taking medications known to influence appetite, food intake or body weight in the past three months;
- Changing their diet and exercise in the last 3 months;
- Having unexpected weight loss in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physical Activity on Appetite and Food Intake in Older Adults
This study aims to assess the effect of physical activity on food intake and appetite in older adults (≥ 65 years) and to investigate the relationship between older adults' eating behaviours, body composition and physical activity.
Read the detailed description
- To investigate the effect of physical activity on food intake and appetite in older adults (≥ 65 years).
- To examine the relationship between older adults' (≥ 65 years) eating behaviours, body composition and physical activity.
- Conditions
- Older Adults, Physical Activity, Food Intake, Eating Behavior, Body Composition
- Keywords
- older adults, appetite, physical activity, food intake, body composition
- Medical subject headings
- Motor Activity, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Status
Physical Activity Status is assessed by using Accelerometers ((AX3) (3-Axis Logging Accelerometer)).
Participants will wear the accelerometers 24-hour for 7 days. Their moderate and vigorous activity hours will be aggregated and based on this data, they will be divided into three groups as vigorous-moderate-low physical activity.
Measured: 7 days
Ratings of Appetite
Appetite is assessed using a 100mm Visual Analogue Scales (VAS, scale 0-100).
Measured: 1 day
Food Intake
Food intake is assessed using a 24-hour weighted food diary.
Measured: 3 days (2 weekdays and 1 weekend day) while the participants are wearing the accelerometer.
Secondary outcomes (16)
Height
Height is measured by using a tape measure.
Measured: Day 1
Weight
Weight is assessed by using a body composition monitor (OMRON Viva).
Measured: Day 1
BMI
BMI is assessed by using a body composition monitor (OMRON Viva).
Measured: Day 1
% fat mass
% fat mass is assessed by using a body composition monitor (OMRON Viva).
Measured: Day 1
% lean body mass
% lean body mass is assessed by using a body composition monitor (OMRON Viva).
Measured: Day 1
Waist Circumference
Waist circumference is measured by using a tape measure.
Measured: Day 1
Hip Circumference
Hip circumference is measured by using a tape measure.
Measured: Day 1
Frailty
Frailty is assessed by using the 'Groingen Frailty Indicator Questionnaire'.
The GFI is a validated, 15-item questionnaire with a score range from zero to fifteen that assesses the physical, cognitive, social, and psychological domains. A GFI score of four or greater is considered the cut-off point for frailty.
Measured: Day 1
Nutritional Knowledge
Nutritional knowledge is assessed by using 'General Nutrition Knowledge Questionnaire'.
This questionnaire consists of four independent sections, each assessing a different aspect of nutrition knowledge: Dietary recommendations; Food groups; Healthy Food choices and Diet, disease and weight management.
Section 1 - Dietary Recommendations Each item carries one point for a correct answer. Maximum score = 18.
Section 2 - Food groups Each item carries one point for a correct answer. Maximum score = 36
Section 3- Healthy Food choices Each item carries one point for a correct answer. Maximum score = 13.
Section 4 - Diet, disease and weight management Each item carries one point for a correct answer. Maximum score = 21.
Measured: Day 1
Appetite Level based on 'Council on Nutrition Appetite Questionnaire'
Appetite level is assessed by using 'Council on Nutrition Appetite Questionnaire'.
The score is calculated by adding up the points (values) that are assigned to the individual answers. The maximum number of points possible for a patient to obtain is 40, while the minimum is 8. The lower the score, the worse the patient's appetite.
8-16: The patient is at risk for anorexia and needs nutrition counselling. 17-28: The patient needs frequent reassessment. >28: The patient is not at risk at this time.
Measured: Day 1
Appetite Level based on 'The three-factor eating questionnaire'
Appetite level is assessed by using 'The three-factor eating questionnaire'.
The TFEQ contains 51 items (questions) and measures three aspects of human eating behaviour: 'cognitive restraint of eating' (Factor I - 21 items); 'disinhibition' (Factor II - 16 items); 'hunger' (Factor III - 14 items). The minimum score for factors I-II-III is, therefore, 0-0-0, the possible maximum score 21-16-14.
Measured: Day 1
Eating Behaviour
Eating behaviour is assessed by using the 'Dutch Eating Behaviour Questionnaire'
The Dutch Eating Behavior Questionnaire is a 33-item self-report questionnaire to assess three distinct eating behaviours in adults: (1) emotional eating, (2) external eating, and (3) restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behaviour.
Measured: Day 1
Food Craving
The experience of food craving is assessed by using the 'Control of Eating Questionnaire'.
The Control of Eating Questionnaire comprises 21-items that are designed to assess the severity and type of food cravings individual experiences over the previous 7 days. The overall score ranges from 0 to 200 and higher scores mean that they have higher severity of food cravings.
Measured: Day 1
Physical Activity Level based on 'General Practice Physical Activity' questionnaire.
Physical activity level is assessed by using 'General Practice Physical Activity Questionnaire'.
This questionnaire provides a simple, 4-level Physical Activity Index (PAI) of - Active, Moderately Active, Moderately Inactive, and Inactive.
Inactive: Sedentary job and no physical exercise or cycling. Moderately inactive: Sedentary job and some but < 1 hour physical exercise and / or cycling per week OR Standing job and no physical exercise or cycling.
Moderately active: Sedentary job and 1-2.9 hours physical exercise and / or cycling per week OR Standing job and some but < 1 hour physical exercise and / or cycling per week OR Physical job and no physical exercise or cycling.
Active: Sedentary job and ≥ 3 hours physical exercise and / or cycling per week OR Standing job and 1-2.9 hours physical exercise and / or cycling per week OR Physical job and some but < 1 hour physical exercise and / or cycling per week OR Heavy manual job.
Measured: Day 1
Physical Activity Level based on 'Physical Activity Scale for the Elderly (PASE)' questionnaire.
Physical activity level is assessed by using 'Physical Activity Scale for the Elderly (PASE)'.
This questionnaire measures the level of self-reported physical activity in individuals aged 65 years or older and is considered of items regarding occupational, household, and leisure activities during the previous 7 day period. The total PASE score is computed by multiplying either the time spent in each activity (hours per week) or participation (i.e., yes/no) in an activity, by empirically derived item weights and then summing overall activities. The overall PASE score ranges from 0 to 400 or more.
Measured: Day 1
Food shopping and cooking behaviors
Food shopping and cooking behaviors is assessed by using 'General Food Shopping and Cooking Questionnaire'.
In this questionnaire, participant's food shopping and cooking behaviours will assess, no scale or score will be reported.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start9 Dec 2020
- Primary completion7 Apr 2021
- Study completion9 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of National Education, Turkey
- Responsible party
- Principal investigator, Miriam Clegg, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067036
- Sponsor's protocol ID
- UREC 20/32
- Status last verified
- Oct 2021
- First submitted
- 2 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non-identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.
Publications
Morley JE, Silver AJ. Anorexia in the elderly. Neurobiol Aging. 1988 Jan-Feb;9(1):9-16. doi: 10.1016/s0197-4580(88)80004-6.
PubMed 2898107Clegg ME, Godfrey A. The relationship between physical activity, appetite and energy intake in older adults: A systematic review. Appetite. 2018 Sep 1;128:145-151. doi: 10.1016/j.appet.2018.05.139. Epub 2018 Jun 7.
PubMed 29885385Clarkston WK, Pantano MM, Morley JE, Horowitz M, Littlefield JM, Burton FR. Evidence for the anorexia of aging: gastrointestinal transit and hunger in healthy elderly vs. young adults. Am J Physiol. 1997 Jan;272(1 Pt 2):R243-8. doi: 10.1152/ajpregu.1997.272.1.R243.
PubMed 9039015Margetts BM, Thompson RL, Elia M, Jackson AA. Prevalence of risk of undernutrition is associated with poor health status in older people in the UK. Eur J Clin Nutr. 2003 Jan;57(1):69-74. doi: 10.1038/sj.ejcn.1601499.
PubMed 12548299Dericioglu D, Methven L, Clegg ME. Does physical activity level and total energy expenditure relate to food intake, appetite, and body composition in healthy older adults? A cross-sectional study. Eur J Nutr. 2025 Jan 24;64(2):71. doi: 10.1007/s00394-024-03571-z.
PubMed 39853478
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity on Appetite and Food Intake in Older Adults
- ClinicalTrials.gov ID
- NCT05067036
- Acronym / sponsor ID
- UREC 20/32
- Conditions
- Older Adults, Physical Activity, Food Intake, Eating Behavior, Body Composition
- Keywords
- older adults, appetite, physical activity, food intake, body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Ministry of National Education, Turkey
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 9 May 2021 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effect of physical activity on food intake and appetite in older adults (≥ 65 years) and to investigate the relationship between older adults' eating behaviours, body composition and physical activity.
Detailed description
- To investigate the effect of physical activity on food intake and appetite in older adults (≥ 65 years).
- To examine the relationship between older adults' (≥ 65 years) eating behaviours, body composition and physical activity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Participants aged older than 65 years.
Key inclusion criteria (3 listed)
- Healthy, living independently and self-reported;
- Aged ≥ 65 years;
- Having the ability to understand the study procedures.
Key exclusion criteria (6 listed)
- Being obese (BMI > 30 kg/m2);
- Smoking more than 10 cigarettes a day;
- Having a disease such as cardiovascular disease and other chronic diseases (diabetes, thyroid disorders, cancer, heart, lung and kidney disease;
- Taking medications known to influence appetite, food intake or body weight in the past three months;
- Changing their diet and exercise in the last 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Activity Status
Time frame: 7 days
Physical Activity Status is assessed by using Accelerometers ((AX3) (3-Axis Logging Accelerometer)). Participants will wear the accelerometers 24-hour for 7 days. Their moderate and vigorous activity hours will be aggregated and based on this data, they will be divided into three groups as vigorous-moderate-low physical activity.
Ratings of Appetite
Time frame: 1 day
Appetite is assessed using a 100mm Visual Analogue Scales (VAS, scale 0-100).
Food Intake
Time frame: 3 days (2 weekdays and 1 weekend day) while the participants are wearing the accelerometer.
Food intake is assessed using a 24-hour weighted food diary.
16 secondary outcomes
Height
Time frame: Day 1
Weight
Time frame: Day 1
BMI
Time frame: Day 1
% fat mass
Time frame: Day 1
% lean body mass
Time frame: Day 1
Waist Circumference
Time frame: Day 1
Hip Circumference
Time frame: Day 1
Frailty
Time frame: Day 1
Nutritional Knowledge
Time frame: Day 1
Appetite Level based on 'Council on Nutrition Appetite Questionnaire'
Time frame: Day 1
Appetite Level based on 'The three-factor eating questionnaire'
Time frame: Day 1
Eating Behaviour
Time frame: Day 1
Food Craving
Time frame: Day 1
Physical Activity Level based on 'General Practice Physical Activity' questionnaire.
Time frame: Day 1
Physical Activity Level based on 'Physical Activity Scale for the Elderly (PASE)' questionnaire.
Time frame: Day 1
Food shopping and cooking behaviors
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Background: PubMed 2898107Morley JE, Silver AJ. Anorexia in the elderly. Neurobiol Aging. 1988 Jan-Feb;9(1):9-16. doi: 10.1016/s0197-4580(88)80004-6.
- Background: PubMed 29885385Clegg ME, Godfrey A. The relationship between physical activity, appetite and energy intake in older adults: A systematic review. Appetite. 2018 Sep 1;128:145-151. doi: 10.1016/j.appet.2018.05.139. Epub 2018 Jun 7.
- Background: PubMed 9039015Clarkston WK, Pantano MM, Morley JE, Horowitz M, Littlefield JM, Burton FR. Evidence for the anorexia of aging: gastrointestinal transit and hunger in healthy elderly vs. young adults. Am J Physiol. 1997 Jan;272(1 Pt 2):R243-8. doi: 10.1152/ajpregu.1997.272.1.R243.
- Background: PubMed 12548299Margetts BM, Thompson RL, Elia M, Jackson AA. Prevalence of risk of undernutrition is associated with poor health status in older people in the UK. Eur J Clin Nutr. 2003 Jan;57(1):69-74. doi: 10.1038/sj.ejcn.1601499.
- Derived from this study: PubMed 39853478Dericioglu D, Methven L, Clegg ME. Does physical activity level and total energy expenditure relate to food intake, appetite, and body composition in healthy older adults? A cross-sectional study. Eur J Nutr. 2025 Jan 24;64(2):71. doi: 10.1007/s00394-024-03571-z.
- NHS. 2018. Exercise as you get olderLink provided by the sponsor.
- Age UK, Healthy eatingLink provided by the sponsor.
- Individual participant dataSharing planned: No. No personal identification data will be shared. The study is not under an obligation to share data, however, it is possible that some of the individual (unliked / non-identifiable) data will be useful in a meta-analysis and, hence sharing individual participant data (IPD) will be considered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Adults and Physical Activity, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Status (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067036, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.