ObesityNCT04768725

Combined Physical-cognitive Exercise and Dietary Intervention for Postmenopausal Obese Women

A study testing Dietary intervention combined with physical-cognitive exergaming, Dietary intervention and Physical-cognitive intervention in people with Obesity, run by Chiang Mai University at 1 site in Thailand.

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

Who is it for?: Ages 45 to 59 years, women only
Conditions the study is for: Obesity
What is being tested?: Dietary intervention combined with physical-cognitive exergaming, Dietary intervention and Physical-cognitive intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteThailand
Study dates: 26 Sep 2021to 5 Dec 2022
Phase: Interventional
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 45 to 59 years
Women only
No healthy volunteers
Adult

Who may be able to join

obese women (body mass index (BMI) ≥ 25 kg/m2 with waist-to-hip ratio (WHR) ≥ 0.80)
post-menopausal (self-reported menstrual characteristics (last menstruation > 1 year) or confirmed by blood follicular stimulating hormone (FSH) level ( > 20 IU/L) and estradiol level ( ≤ 30 pg/ml))
sedentary lifestyle (exercise < 1 hr./wk.)
normal range of the Mental State Examination T10 (MSET10) score
at least 6 years of education
own a mobile phone that supports application platform
able to comply with the study schedule and procedures

Who cannot join

have medical conditions that would be unsafe to exercise or have been diagnosed with neurological conditions (e.g. Parkinson's disease, stroke, multiple sclerosis) that affect cognition and mobility
have weight variation ( > 5 kilogram in 3 months)
have other dietary restrictions (e.g. vegetarianism and veganism)
have depressive symptoms defined as a score ≥ 11 on Hospital Anxiety Depression Scale (HADS)
have an uncorrected visual or hearing impairment
receive hormonal replacement therapy

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University
Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: A Randomized Controlled Trial Investigating the Effects of Combined Physical-cognitive Exercise and Dietary Intervention on Cognitive Performance and Changes in Blood Biomarkers of Postmenopausal Obese Women

This study aims to examine the effects of dietary intervention combined with physical-cognitive exergaming on cognitive performance and circulating biomarkers of obese postmenopausal women. It is hypothesized that participants will demonstrate significant improvement in cognitive performance and circulating biomarkers after participating in this combined program compared to baseline and the dietary and control groups.

Read the detailed description

An association between obesity and cognitive impairment has been consistently reported. The risk of having dementia in later life is about 74% higher for middle-aged obese individuals than those with normal BMI. Estrogen deprivation has also been found to impair cognition. Thus, obese postmenopausal women are likely to be at risk of having cognitive impairment. The common recommendation for obesity management is dietary and exercise intervention. Research evidence has demonstrated that either dietary intervention or moderate-vigorous intensity exercise enhance cognitive function in obese adults. This study aims to examine the effects of 12-week home-based dietary intervention combined with physical-cognitive exergaming on cognitive performance and circulating biomarkers of obese postmenopausal women through a randomised controlled trial. Participants will be randomly assigned to one of the four groups: 1) dietary intervention 2) combined physical-cognitive exergaming, 3) dietary intervention combined with physical-cognitive exergaming, and 4) control group. Outcome measures including cognitive performance (i.e. executive function, episodic memory, attention, language, and global cognition), circulating biomarkers (i.e. BDNF level, metabolic parameters, inflammation markers, and adiponectin levels) as well as physical performance will be determined at baseline and after 12-week intervention. Findings from this study may offer a feasible and effective intervention program to improve cognitive performance along with its responsible circulating biomarkers in obese postmenopausal women.

Conditions: Obesity
Being tested: Dietary intervention combined with physical-cognitive exergaming, Dietary intervention, Physical-cognitive intervention
Keywords: Dietary intervention, Cognitive function, Brain-derived neurotrophic factor, Exergaming, Obesity
Medical subject headings: Obesity

What participants receive

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

Dietary intervention combined with physical-cognitive exergamingBehavioural
Intermittent Fasting (IF) [self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)] combined with physical-cognitive exercise [60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)].
Dietary interventionBehavioural
Intermittent Fasting (IF) [self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)].
Physical-cognitive interventionBehavioural
Physical-cognitive exercise [60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)].

Study groups in NCT04768725
Study group	Role	What they receive
Dietary intervention	Active comparator	Participants will consume a self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day). Receives: Behavioral: Dietary intervention
Physical-cognitive intervention	Active comparator	Participants will perform home-based physical-cognitive training for 60 minutes per session, 3 session a week. Receives: Behavioral: Physical-cognitive intervention
Physical-cognitive with dietary intervention	Experimental	Participants will receive both dietary intervention and physical-cognitive training same as those in the dietary and physical-cognitive intervention groups. Receives: Behavioral: Dietary intervention combined with physical-cognitive exergaming
Control	No intervention	Participants in the control group will be encouraged to continue their activities and calorie intakes as they usually would.

What is being measured

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

change from baseline time to complete Trail Making B-A at 12 weeks
Time to complete Trail Making B and A will be recorded in seconds. The difference between time to complete Trail B and A will be used to index the task switching ability, a subdomain of executive function. Smaller differences between B-A indicate better switching ability.
Measured: 12 weeks
change from baseline Stroop Color and Word score at 12 weeks
In Stroop Color and Word test, the number of items correctly identified in 45 seconds in each condition (i.e. word, color, color-word) will be recorded. Then the predicted score will be calculated. Score will be obtained from the different between the color-word and predicted scores. Lower scores indicate greater difficulty in inhibiting interference.
Measured: 12 weeks
change from baseline Logical Memory score at 12 weeks
In Logical Memory test, participants will be instructed to listen carefully to two stories and remember their contents. After a 30-delay, they will be asked to freely recall the passages (recall) and respond yes or no to the given questions (recognition). The possible scores are 0-75. Higher scores indicate better episodic memory.
Measured: 12 weeks
change from baseline Brain-derived neurotrophic factor (BDNF) level at 12 weeks
Level of plasma BDNF will be determined before and after the intervention.
Measured: 12 weeks

Secondary outcomes (8)

change from baseline Montreal Cognitive Assessment (MoCA) score at 12 weeks
The Montreal Cognitive Assessment will be used to index global cognitive function. The possible scores are 0-30. Higher scores indicate better cognitive function.
Measured: 12 weeks
change from baseline Verbal Fluency score at 12 weeks
Category fluency subtest (naming test) of Verbal Fluency will be used. Participants will be asked to produce as many words as possible in 60 seconds. Higher scores indicate better language ability.
Measured: 12 weeks
change from baseline Digit Span score at 12 weeks
In Digit Span test, lists of numbers will be presented orally to participants. They are asked to repeat the numbers immediately in ascending (forward) or reverse (backward) numerical order. The possible scores are 0-28. Higher scores indicate better attention.
Measured: 12 weeks
change from baseline plasma adiponectin levels at 12 weeks
Level of plasma adiponectin will be determined before and after intervention.
Measured: 12 weeks
change from baseline plasma Interleukin 6 (IL-6) levels at 12 weeks
Level of plasma IL-6 will be determined before and after intervention.
Measured: 12 weeks
change from baseline insulin resistance levels at 12 weeks
Level of insulin resistance will be assessed using the homeostasis model assessment (HOMA-IR) index [fasting glucose (mg/dL) X fasting insulin (µU/mL) / 405].
Measured: 12 weeks
change from baseline Six-minute walk distance at 12 weeks
The distance (in meters) participants walked in 6 minutes will be determined. Longer distance indicates better cardiorespiratory fitness.
Measured: 12 weeks
change from baseline 30 seconds Chair Stand Test at 12 weeks
The number of repetitions participants could perform sit-to-stand will be recorded. Higher number of repetitions indicates greater lower-body strength.
Measured: 12 weeks

Timeline

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

26 Sep 20215 Dec 2022

First posted24 Feb 2021
Study start26 Sep 2021
Primary completion3 Dec 2022
Study completion5 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04768725
Sponsor's protocol ID: AMS-PT CMU 2564
Status last verified: Feb 2023
First submitted: 5 Feb 2021
Last updated: 14 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Keawtep P, Sungkarat S, Boripuntakul S, Sa-Nguanmoo P, Wichayanrat W, Chattipakorn SC, Worakul P. Effects of combined dietary intervention and physical-cognitive exercise on cognitive function and cardiometabolic health of postmenopausal women with obesity: a randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Mar 5;21(1):28. doi: 10.1186/s12966-024-01580-z.
PubMed 38443944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial Investigating the Effects of Combined Physical-cognitive Exercise and Dietary Intervention on Cognitive Performance and Changes in Blood Biomarkers of Postmenopausal Obese Women
ClinicalTrials.gov ID: NCT04768725
Acronym / sponsor ID: AMS-PT CMU 2564
Conditions: Obesity
Keywords: Dietary intervention, Cognitive function, Brain-derived neurotrophic factor, Exergaming, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Chiang Mai UniversityUniversity, hospital or other
Study start: 26 Sep 2021 (actual)
Primary completion: 3 Dec 2022 (actual)
Study completion: 5 Dec 2022 (actual)
First posted: 24 Feb 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Dietary intervention	Active comparator	Behavioral: Dietary interventionParticipants will consume a self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day).
Physical-cognitive intervention	Active comparator	Behavioral: Physical-cognitive interventionParticipants will perform home-based physical-cognitive training for 60 minutes per session, 3 session a week.
Physical-cognitive with dietary intervention	Experimental	Behavioral: Dietary intervention combined with physical-cognitive exergamingParticipants will receive both dietary intervention and physical-cognitive training same as those in the dietary and physical-cognitive intervention groups.
Control	No intervention	–Participants in the control group will be encouraged to continue their activities and calorie intakes as they usually would.

Who may qualify

Ages: 45 to 59 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

obese women (body mass index (BMI) ≥ 25 kg/m2 with waist-to-hip ratio (WHR) ≥ 0.80)
post-menopausal (self-reported menstrual characteristics (last menstruation > 1 year) or confirmed by blood follicular stimulating hormone (FSH) level ( > 20 IU/L) and estradiol level ( ≤ 30 pg/ml))
sedentary lifestyle (exercise < 1 hr./wk.)
normal range of the Mental State Examination T10 (MSET10) score
at least 6 years of education

Key exclusion criteria (6 listed)

have medical conditions that would be unsafe to exercise or have been diagnosed with neurological conditions (e.g. Parkinson's disease, stroke, multiple sclerosis) that affect cognition and mobility
have weight variation ( > 5 kilogram in 3 months)
have other dietary restrictions (e.g. vegetarianism and veganism)
have depressive symptoms defined as a score ≥ 11 on Hospital Anxiety Depression Scale (HADS)
have an uncorrected visual or hearing impairment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dietary intervention combined with physical-cognitive exergamingIntermittent Fasting (IF) [self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)] combined with physical-cognitive exercise [60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)].	Behavioural	Physical-cognitive with dietary intervention
Dietary interventionIntermittent Fasting (IF) [self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)].	Behavioural	Dietary intervention
Physical-cognitive interventionPhysical-cognitive exercise [60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)].	Behavioural	Physical-cognitive intervention

Primary outcome

change from baseline time to complete Trail Making B-A at 12 weeks
Time frame: 12 weeks
Time to complete Trail Making B and A will be recorded in seconds. The difference between time to complete Trail B and A will be used to index the task switching ability, a subdomain of executive function. Smaller differences between B-A indicate better switching ability.
change from baseline Stroop Color and Word score at 12 weeks
Time frame: 12 weeks
In Stroop Color and Word test, the number of items correctly identified in 45 seconds in each condition (i.e. word, color, color-word) will be recorded. Then the predicted score will be calculated. Score will be obtained from the different between the color-word and predicted scores. Lower scores indicate greater difficulty in inhibiting interference.
change from baseline Logical Memory score at 12 weeks
Time frame: 12 weeks
In Logical Memory test, participants will be instructed to listen carefully to two stories and remember their contents. After a 30-delay, they will be asked to freely recall the passages (recall) and respond yes or no to the given questions (recognition). The possible scores are 0-75. Higher scores indicate better episodic memory.
change from baseline Brain-derived neurotrophic factor (BDNF) level at 12 weeks
Time frame: 12 weeks
Level of plasma BDNF will be determined before and after the intervention.

8 secondary outcomes

change from baseline Montreal Cognitive Assessment (MoCA) score at 12 weeks
Time frame: 12 weeks
change from baseline Verbal Fluency score at 12 weeks
Time frame: 12 weeks
change from baseline Digit Span score at 12 weeks
Time frame: 12 weeks
change from baseline plasma adiponectin levels at 12 weeks
Time frame: 12 weeks
change from baseline plasma Interleukin 6 (IL-6) levels at 12 weeks
Time frame: 12 weeks
change from baseline insulin resistance levels at 12 weeks
Time frame: 12 weeks
change from baseline Six-minute walk distance at 12 weeks
Time frame: 12 weeks
change from baseline 30 seconds Chair Stand Test at 12 weeks
Time frame: 12 weeks

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 14 Feb 2023.
Derived from this study: PubMed 38443944Keawtep P, Sungkarat S, Boripuntakul S, Sa-Nguanmoo P, Wichayanrat W, Chattipakorn SC, Worakul P. Effects of combined dietary intervention and physical-cognitive exercise on cognitive function and cardiometabolic health of postmenopausal women with obesity: a randomized controlled trial. Int J Behav Nutr Phys Act. 2024 Mar 5;21(1):28. doi: 10.1186/s12966-024-01580-z.

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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.

Somporn Sungkarat, PhD principal investigator

Chiang Mai University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 14 Feb 2023. 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 Thailand. 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?

change from baseline time to complete Trail Making B-A at 12 weeks (time frame: 12 weeks). The study lists 4 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 NCT04768725, which also lists 1 linked publication.

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 14 Feb 2023.