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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-26

Study Completion Date

2022-12-05

Brief Summary

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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.

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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dietary intervention

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).

Group Type ACTIVE_COMPARATOR

Dietary intervention

Intervention Type BEHAVIORAL

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 intervention

Participants will perform home-based physical-cognitive training for 60 minutes per session, 3 session a week.

Group Type ACTIVE_COMPARATOR

Physical-cognitive intervention

Intervention Type BEHAVIORAL

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)\].

Physical-cognitive with dietary intervention

Participants will receive both dietary intervention and physical-cognitive training same as those in the dietary and physical-cognitive intervention groups.

Group Type EXPERIMENTAL

Dietary intervention combined with physical-cognitive exergaming

Intervention Type BEHAVIORAL

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)\].

Control

Participants in the control group will be encouraged to continue their activities and calorie intakes as they usually would.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietary intervention combined with physical-cognitive exergaming

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)\].

Intervention Type BEHAVIORAL

Dietary intervention

Intermittent Fasting (IF) \[self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)\].

Intervention Type BEHAVIORAL

Physical-cognitive intervention

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)\].

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No