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

Chiang Mai University

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Dietary intervention; Behavioral: Physical-cognitive intervention; Behavioral: Dietary intervention combined with physical-cognitive exergaming

Study type: Interventional

Funder types: Other

Identifiers

NCT04768725

AMS-PT CMU 2564

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Female

Ages: 45 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 4 patient groups

Dietary intervention

Active Comparator group

Description:

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).

Treatment:

Behavioral: Dietary intervention

Physical-cognitive intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Physical-cognitive intervention

Physical-cognitive with dietary intervention

Experimental group

Description:

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

Treatment:

Behavioral: Dietary intervention combined with physical-cognitive exergaming

Control

No Intervention group

Description:

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