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

NCT04768725 | Completed

• 1 other identifier: AMS-PT CMU 2564
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Dietary intervention; Cognitive function; Brain-derived neurotrophic factor; Exergaming; Obesity

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  12 weeks

Secondary Outcomes (8)

• change from baseline Montreal Cognitive Assessment (MoCA) score at 12 weeks

  12 weeks

• change from baseline Verbal Fluency score at 12 weeks

  12 weeks

• change from baseline Digit Span score at 12 weeks

  12 weeks

• change from baseline plasma adiponectin levels at 12 weeks

  12 weeks

• change from baseline plasma Interleukin 6 (IL-6) levels at 12 weeks

  12 weeks

Study Arms (4)

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).

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.

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.

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.

Interventions

Dietary intervention combined with physical-cognitive exergaming 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)\].

Physical-cognitive with dietary intervention

Dietary intervention BEHAVIORAL

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

Dietary intervention

Physical-cognitive intervention 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 intervention

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

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

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

• 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.

  PMID: 38443944 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Somporn Sungkarat, PhD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 24, 2021
• Study Start: September 26, 2021
• Primary Completion: December 3, 2022
• Study Completion: December 5, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

TH (1)