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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United Kingdom1 site
  • University of Reading

    Reading

Other trials in United Kingdom

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.
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.

  1. 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

  2. Ratings of Appetite

    Appetite is assessed using a 100mm Visual Analogue Scales (VAS, scale 0-100).

    Measured: 1 day

  3. 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)
  1. Height

    Height is measured by using a tape measure.

    Measured: Day 1

  2. Weight

    Weight is assessed by using a body composition monitor (OMRON Viva).

    Measured: Day 1

  3. BMI

    BMI is assessed by using a body composition monitor (OMRON Viva).

    Measured: Day 1

  4. % fat mass

    % fat mass is assessed by using a body composition monitor (OMRON Viva).

    Measured: Day 1

  5. % lean body mass

    % lean body mass is assessed by using a body composition monitor (OMRON Viva).

    Measured: Day 1

  6. Waist Circumference

    Waist circumference is measured by using a tape measure.

    Measured: Day 1

  7. Hip Circumference

    Hip circumference is measured by using a tape measure.

    Measured: Day 1

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.

  1. First posted4 Oct 2021
  2. Study start9 Dec 2020
  3. Primary completion7 Apr 2021
  4. Study completion9 May 2021

Resources

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)
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 2898107
  • Clegg 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 29885385
  • Clarkston 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 9039015
  • Margetts 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 12548299
  • Dericioglu 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

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.

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