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Obesity & OverweightCOMPASS65+NCT07289529

COMPASS 65+ - Community-based Physical Activity Snacks for Healthy Aging in Overweight and Obese Aged Adults

A study testing Group-based "Snack Exercise" Training and Prescription and Brief educational counseling session in people with Obesity & Overweight and Aged 65 Years or Older, run by University of Coimbra at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will explore a new way for older adults to become more physically active. As people get older, it's common to gain weight and lose muscle strength. This combination can make it harder to do daily activities, increase the risk of falls, and impact overall quality of life. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Obesity & Overweight, Aged 65 Years or Older
What is being tested?
Group-based "Snack Exercise" Training and Prescription and Brief educational counseling session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePortugal
Study dates
Sep 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • adults aged ≥65 years with a BMI ≥25 kg/m².

Who cannot join

  • significant cognitive deficits,
  • contraindications to exercise (assessed via PAR-Q+),
  • major cardiovascular events within the last 3 months,
  • unstable chronic disease,
  • severe mobility impairment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Susana PP Miguel, MSc, MD contact

+351 918927441

susanappmiguel@gmail.com

Portugal1 site

  • Fernão de Magalhães Health Center

    Coimbra, 3000

    Susana P Miguel, MSc, MD

Other trials in Portugal

About this study

This study will explore a new way for older adults to become more physically active. As people get older, it's common to gain weight and lose muscle strength. This combination can make it harder to do daily activities, increase the risk of falls, and impact overall quality of life. While we know that regular exercise is very beneficial, many older adults find it difficult to stick to traditional exercise programs due to lack of time, motivation, or energy.

This research project, called COMPASS 65+, will test an innovative approach called "snack exercise." Instead of one long workout, "snack exercise" involves doing several short bouts of activity, a few minutes at a time, throughout the day. The main idea is that these short, frequent bouts of activity might be easier to fit into a daily routine and less tiring than longer exercise sessions.

Read more

The purpose of this study is to see if a "snack exercise" program is a feasible and enjoyable way for adults aged 65 and over, who are overweight or obese, to improve their health. The study will be conducted in two main parts. First, the research team will talk with older adults to understand what helps or hinders them from being active to co-design the program. Second, volunteers will be randomly assigned to either a "snack exercise" group or a control group.

Participants in the "snack exercise" group will attend sessions that combine theory and practice to learn how to perform these exercises and will receive individualized prescriptions to perform the "snacks" (short bouts) at home. The control group will receive a brief educational counselling session on physical activity. Participants' health status, body composition, and physical fitness will be assessed at baseline, after the 12 weeks intervention, and again 6 weeks post-intervention to evaluate the maintenance of any improvements. These outcomes will help determine whether short bouts of 'exercise snacking' constitute a feasible and effective strategy to promote functional capacity, metabolic health, and long-term adherence to physical activity.

Read the detailed description

Study Rationale and Background The intersection of an aging population and the obesity epidemic poses a significant public health challenge, particularly for adults aged 65 and older. This combination often leads to sarcopenic obesity, a condition characterized by excess body fat and low muscle mass and strength, which substantially increases the risk of falls, frailty, functional decline, and loss of independence. While physical activity is a proven non-pharmacological intervention to counteract these declines, adherence to traditional, structured exercise programs remains low among older adults. Barriers such as a perceived lack of time, low motivation, and fatigue create a gap between the known benefits of exercise and its practical implementation in real-world community settings.

This study, COMPASS 65+, proposes to evaluate an innovative exercise modality known as "snack exercise." This approach involves short, frequent bouts of physical activity performed throughout the day, designed to be more accessible and less burdensome than conventional exercise routines. The primary aim of this project is to assess the feasibility, acceptability, and preliminary effects of a community-based "snack exercise" program, co-designed with input from the target population, for overweight and obese older adults. The findings are intended to provide the necessary evidence to design a future, definitive large-scale randomized controlled trial (RCT).

Study Design

The research plan is structured in two sequential phases:

  1. Phase 1: Exploratory Mixed-Methods Study This initial phase is designed to inform the development of the intervention. It involves a mixed-methods approach to identify barriers, facilitators, and preferences related to physical activity among the target population.
  • Quantitative Component: A cross-sectional survey will be administered to a convenience sample of 370 adults aged 65 or older with a Body Mass Index (BMI) of 25 kg/m² or greater. The survey will include validated instruments such as the Exercise Benefits/Barriers Scale (EBBS) and the Multimorbidity Treatment Burden Questionnaire (MTBQ).
  • Qualitative Component: Focus groups will be conducted with a randomly selected subset of the target population to explore user preferences for program design.The data will be integrated to co-design a "snack exercise" intervention that is evidence-based and tailored to user needs.
  1. Phase 2: Feasibility Randomized Controlled Trial (RCT) A two-arm, parallel-group feasibility RCT will be conducted to test the co-designed intervention.
  • Participants: A target of 60 participants will be recruited from primary care settings. Inclusion criteria include adults aged ≥ 65 years with a BMI ≥ 25 kg/m². Exclusion criteria include significant cognitive deficits, contraindications to exercise (assessed via PAR-Q+), major cardiovascular events within the last 3 months, unstable chronic disease, or severe mobility impairment.
  • Randomization: Participants will be randomly allocated (1:1) to either the intervention group or the control group.
  • Timeline: The intervention lasts 12 weeks, followed by a 6-week post-intervention "washout" period. Assessments occur at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).
  • Intervention Groups Active Comparator (Control Group): Participants will receive a single, standardized Brief Educational Counselling Session (60 minutes) at baseline (T0). Delivered by trained research personnel, this session provides foundational information on the benefits of physical activity for healthy aging and offers practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline.

Experimental Group ("Snack Exercise"): Participants will receive the standardized Brief Educational Counselling Session at baseline, followed by the Structured Community-based Physical Activity Snack Intervention. This program consists of group-based, theoretico-practical sessions held 2-3 times per week, each lasting approximately 45 minutes. Sessions are guided by a physical exercise professional and focus on explaining and practicing the prescribed snack exercises. Crucially, at the end of each session, participants are provided with an individualized physical prescription to perform at home. Exercise intensity is monitored using perceived exertion scales (BORG-OMNI), progressing from light to moderate intensity per WHO recommendations.

Study Procedures and Outcome Measures Protocol \& Ethics: The study adheres to SPIRIT guidelines and the Declaration of Helsinki, with Ethics Committee approval and written informed consent required.

Outcomes \& Data Collection: Comprehensive assessments are conducted at T0, T1, and T2 using validated instruments and objective tools:

  • Body Composition \& Anthropometrics: Dual-Energy X-ray Absorptiometry (DEXA) for fat/lean mass and bone density; Height, Weight, BMI (kg/m^2), and Waist Circumference.
  • Cardiorespiratory Fitness: One-Mile Walk Test to predict aerobic capacity (VO2 max).
  • Functional Fitness \& Fall Risk: The Short Physical Performance Battery (SPPB) (assessing balance, gait speed, and chair stands) and the 30-second Chair Stand Test (muscular endurance).
  • Stability: Limits of stability assessed via a force platform (Physiosensing®).
  • Daily Physical Activity: Objectively measured using a Fitband worn for five consecutive days (step count, active minutes).
  • Psychosocial \& Health Status: Exercise Self-Efficacy Scale (ESES).
  • Multidimensional Lifestyle and Health Status (assessed via the Healthy Lifestyle Assessment Toolkit, covering cardiometabolic health, well-being, nutrition, mental health, and sleep).

Statistical Analysis Plan Primary Analysis (Feasibility): Descriptive analysis of recruitment, adherence, retention, and protocol fidelity based on the RE-AIM framework.

Secondary Analysis (Preliminary Effects): Repeated measures ANOVA or mixed models will be used to assess changes over time (T0, T1, T2) and between groups (p< 0.05). The goal is to estimate effect sizes to power a future definitive trial.

Data Management: All analyses will be conducted using SPSS (Version 29), with appropriate handling of missing data (e.g., multiple imputation).

Being tested
Group-based "Snack Exercise" Training and Prescription, Brief educational counseling session
Keywords
Aged, Overweight, Snack exercise, Community Health Planning
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group-based "Snack Exercise" Training and PrescriptionBehavioural

    This programme consists of supervised, group-based sessions (2-3 per week, ~45 minutes each) combining concise theoretical instruction with guided practical execution of the snack-exercise protocol. Sessions are delivered by a qualified exercise professional and focus on teaching correct technique, safety, and progression of the prescribed short exercise bouts ("exercise snacks").

    At the end of each session, participants receive an individualized home-based exercise prescription, tailored to their functional capacity and progression markers. Exercise intensity during supervised and home practice is monitored using the OMNI-BORG perceived exertion scale, progressing from light to moderate intensity, in accordance with World Health Organization recommendations.

  • Brief educational counseling sessionBehavioural

    A standardized brief educational counseling session delivered by trained research personnel during the baseline assessment. This session will provide foundational information on the benefits of physical activity for healthy aging and offer practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline for both study arms.

Study groups in NCT07289529
Study groupRoleWhat they receive
Brief educational counselling sessionActive comparatorParticipants will receive a brief educational counselling session (60 minutes) at the baseline assessment. This session will be a standardized brief educational counseling session delivered by trained research personnel during the baseline assessment. This session will provide foundational information on the benefits of physical activity for healthy aging and offer practical strategies for incorporating short "physical activity snacks" into daily routines. This ensures a consistent educational baseline for both study arms.
Receives: Behavioral: Brief educational counseling session
Brief educational counselling session + Group-based "Snack Exercise" training and prescriptionActive comparatorParticipants will receive a standardized Brief Educational Counselling Session at baseline. This group will then proceed with the Structured Community-based Physical Activity Snack Intervention (COMPASS 65+). The program will consist of group-based, theory-based and practical sessions (held 2-3 times per week, each lasting approximately 45 minutes).
Receives: Behavioral: Group-based "Snack Exercise" Training and Prescription; Behavioral: Brief educational counseling session

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate (Reach)

    The percentage of eligible individuals who consent to participate in the study out of all individuals invited. This will be a measure of the reach and appeal of the intervention and study design.

    Measured: From the start of recruitment until the target sample size is reached (approximately 2 months).

  2. Adherence to the "Snack Exercise" Program (Effectiveness)

    The percentage of scheduled "snack exercise" sessions attended by participants in the intervention group. Adherence will be calculated as (number of sessions attended / total number of scheduled sessions) x 100. This measures the effectiveness of the program in engaging participants.

    Measured: Throughout the 12-week intervention period.

  3. Program Implementation Fidelity (Implementation)

    The degree to which the "snack exercise" program is delivered as intended by the study protocol. This will be assessed by a checklist monitoring staff adherence to the protocol, including session content, duration, and intensity monitoring procedures. It will be measured as a percentage of protocol items successfully delivered.

    Measured: Throughout the 12-week intervention period.

  4. Participant Retention Rate

    The percentage of enrolled participants who complete all study assessments at all time points (T0, T1, and T2). This measures the overall acceptability of the study procedures and the ability to retain participants over the full duration.

    Measured: From baseline (T0) to the final follow-up assessment (T2) at 18 weeks.

  5. Intention to Continue Exercise (Maintenance)

    Assessed via a self-report questionnaire administered at the final follow-up visit, evaluating participants' intention and confidence to continue with "snack exercise" or other forms of physical activity independently after the study concludes.

    Measured: At the final follow-up assessment (T2) at 18 weeks.

Secondary outcomes (12)

  1. Multidimensional Lifestyle and Health Status

    Evaluated using the Healthy Lifestyle Assessment Toolkit, a comprehensive instrument that assesses multiple domains including cardiometabolic health (blood pressure), well-being, nutrition, mental health, sleep quality, and self-perceived health status. The toolkit identify risks and guide interventions, using systems like traffic light scores (green/yellow/orange) for feedback and promoting behavior change for better health outcomes.

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  2. Daily Physical Activity Patterns

    Objectively measured using a triaxial accelerometer (worn on the hip for 5-7 consecutive days). Participants will be instructed to wear the device during all waking hours, removing it only for water-based activities or sleeping. The accelerometers provided objective measures of daily movement patterns, including step count, time spent in different activity intensities, and sedentary behavior. This approach allow us to evaluate changes in physical activity levels throughout the intervention and to assess adherence.

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  3. Body Composition - Dual-Energy X-ray Absorptiometry (DEXA)

    Assessed using Dual-Energy X-ray Absorptiometry (DEXA) to measure changes in fat mass, lean mass, and bone mineral density.

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  4. Anthropometrics - Height

    Anthropometric measures including height - height in meters (m).

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  5. Anthropometrics - Weight

    Anthropometric measures including Weight - weight in kilograms (kg).

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  6. Anthropometrics - Body Mass Index (BMI)

    Anthropometric measures including Body Mass Index (BMI) - weight in kilograms by height in meters squared (kg/m^2).

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  7. Anthropometrics - Waist circumference

    Anthropometric measures including waist circumference will also be collected - waist circumference in cm.

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  8. Cardiorespiratory Fitness

    Assessed using the One-Mile Walk Test (1,61 kilometers) for evaluation of cardiovascular fitness, to predict an individual's aerobic capacity, also known as maximal oxygen consumption (VO2 max).

    A slower time indicates lower cardiorespiratory fitness, and it's also a strong predictor of health outcomes.

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  9. Functional Fitness (muscular endurance)

    A battery of tests will be used, including the 30-second chair stand test for muscular endurance. This measures lower body muscular endurance by counting how many times a person can stand up from a chair and sit back down in 30 seconds, using arms folded across the chest for support.

    Scores decline with age. A below average score (in seconds) indicates a risk for falls, being the cut off for each age group:

    65-69: < 12 (M); < 11 (W) 70-74: < 12 (M); < 10 (W) 75-79: < 11 (M); < 10 (W) 80-84: < 10 (M); < 9 (W) 85-89: < 8 (M); < 8 (W) 90-94: < 7 (M); < 4 (W)

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  10. Functional Fitness and Fall risk - Short Physical Performance Battery (SPPB)

    A battery of tests will be used, including the Short Physical Performance Battery (SPPB) for functional capacity and fall risk. This is an objective test for older adults assessing lower-body function via 3 tasks: standing balance, usual gait speed (4m walk), and chair stands (5 reps, arms crossed). Scoring 0-12 (higher is better), predict disability, falls, hospitalization, and mortality, and is highly reliable for measuring physical capability in various settings.

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  11. Fall Risk and Functional stability (force platform)

    Assessment of limits of stability using a force platform for functional stability (Physiosensing® v.19002, Sensing Future, Coimbra, Portugal).

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

  12. Exercise Self-Efficacy (ESES)

    Assessed using the Exercise Self-Efficacy Scale (ESES), a self-report measure to evaluate participants' confidence in their ability to engage in exercise. Participants answer on a 4-point rating scale, possible scoring range 10-40. A higher total score means greater exercise self-efficacy (stronger belief in one's ability to exercise).

    Measured: Assessed at baseline (T0), post-intervention (T1, 12 weeks), and follow-up (T2, 18 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07289529
Sponsor's protocol ID
2025.08868.SAU+
Other IDs
2025
Acronym
COMPASS65+
Status last verified
Dec 2025
First submitted
19 Nov 2025
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: A plan for sharing individual participant data with external researchers has not been established at this stage for several reasons. Primarily, this is a feasibility study with a small sample size, designed to inform the design of a future, larger trial rather than to produce generalizable findings. Due to the small cohort and specific regional recruitment, there is a potential risk of deductive disclosure of participant identity, even with de-identified data. Furthermore, the informed consent obtained from participants does not include a specific clause for sharing their individual data beyond the core research team for secondary research purposes. Therefore, to uphold ethical commitments to participant confidentiality, IPD will not be made available at the conclusion of this study.

Publications

  • Reis F, Sa-Moura B, Guardado D, Couceiro P, Catarino L, Mota-Pinto A, Verissimo MT, Teixeira AM, Ferreira PL, Lima MP, Palavra F, Rama L, Santos L, van der Heijden RA, Goncalves CE, Cunha A, Malva JO. Development of a Healthy Lifestyle Assessment Toolkit for the General Public. Front Med (Lausanne). 2019 Jun 27;6:134. doi: 10.3389/fmed.2019.00134. eCollection 2019.

    PubMed 31316985

  • Vancea A, Iliescu M, Aivaz KA, Popescu MN, Beiu C, Spiru L. Improving Functional Capacities and Well-Being in Older Adults: Strategies in Physical Medicine and Rehabilitation. Cureus. 2024 Aug 6;16(8):e66254. doi: 10.7759/cureus.66254. eCollection 2024 Aug.

    PubMed 39238764

  • Rodrigues RN, Carballeira E, Silva F, Caldo-Silva A, Abreu C, Furtado GE, Teixeira AM. The Effect of a Resistance Training, Detraining and Retraining Cycle on Postural Stability and Estimated Fall Risk in Institutionalized Older Persons: A 40-Week Intervention. Healthcare (Basel). 2022 Apr 22;10(5):776. doi: 10.3390/healthcare10050776.

    PubMed 35627913

  • Nuzzo JL, Pinto MD, Kirk BJC, Nosaka K. Resistance Exercise Minimal Dose Strategies for Increasing Muscle Strength in the General Population: an Overview. Sports Med. 2024 May;54(5):1139-1162. doi: 10.1007/s40279-024-02009-0. Epub 2024 Mar 20.

    PubMed 38509414

  • Lee PG, Jackson EA, Richardson CR. Exercise Prescriptions in Older Adults. Am Fam Physician. 2017 Apr 1;95(7):425-432.

    PubMed 28409595

  • Hashimoto K, Dora K, Murakami Y, Matsumura T, Yuuki IW, Yang S, Hashimoto T. Positive impact of a 10-min walk immediately after glucose intake on postprandial glucose levels. Sci Rep. 2025 Jul 2;15(1):22662. doi: 10.1038/s41598-025-07312-y.

    PubMed 40594496

  • Evans K, Abdelhafiz D, Abdelhafiz AH. Sarcopenic obesity as a determinant of cardiovascular disease risk in older people: a systematic review. Postgrad Med. 2021 Nov;133(8):831-842. doi: 10.1080/00325481.2021.1942934. Epub 2021 Jul 12.

    PubMed 34126036

  • Eitmann S, Matrai P, Hegyi P, Balasko M, Eross B, Dorogi K, Petervari E. Obesity paradox in older sarcopenic adults - a delay in aging: A systematic review and meta-analysis. Ageing Res Rev. 2024 Jan;93:102164. doi: 10.1016/j.arr.2023.102164. Epub 2023 Dec 14.

    PubMed 38103840

  • Collado-Mateo D, Lavin-Perez AM, Penacoba C, Del Coso J, Leyton-Roman M, Luque-Casado A, Gasque P, Fernandez-Del-Olmo MA, Amado-Alonso D. Key Factors Associated with Adherence to Physical Exercise in Patients with Chronic Diseases and Older Adults: An Umbrella Review. Int J Environ Res Public Health. 2021 Feb 19;18(4):2023. doi: 10.3390/ijerph18042023.

    PubMed 33669679

  • Campisi J, Kapahi P, Lithgow GJ, Melov S, Newman JC, Verdin E. From discoveries in ageing research to therapeutics for healthy ageing. Nature. 2019 Jul;571(7764):183-192. doi: 10.1038/s41586-019-1365-2. Epub 2019 Jul 10.

    PubMed 31292558

Questions about this trial

What is this clinical trial studying?

A study testing Group-based "Snack Exercise" Training and Prescription and Brief educational counseling session in people with Obesity & Overweight and Aged 65 Years or Older, run by University of Coimbra at 1 site in Portugal.

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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 29 Apr 2026. 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 Portugal. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Susana PP Miguel, MSc, MD (+351 918927441, susanappmiguel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (Reach) (time frame: From the start of recruitment until the target sample size is reached (approximately 2 months).). The study lists 5 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 NCT07289529, which also lists 10 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 29 Apr 2026.

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