Clinical trial NCT04016909: The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
Official title: The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: brain activity
cognitive function
diet
exercise
motor behavior
psychosocial state
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 26
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The benefits of weight-loss programs on mood state and cognitive and motor behavior remain unclear and are largely limited to those of calorie restriction (CR) or physical exercise alone. Our aim was to investigate the effect of a combined CR and aerobic exercise program on mood state, cognition-related brain activity, and cognitive and motor behavior in overweight and obese women. Twenty-six overweight or obese women were randomized to either a control group (no intervention) or an experimental group (aerobic exercise + 12.5% energy-intake reduction). Brain-derived neurotrophic factor (BDNF) levels, mood, prefrontal cortex activity, cognitive performance, and learning of a speed-accuracy task were evaluated before and 6 months after the beginning of the program. Confusion and depression increased in the control group (P \< 0.05), whereas tension decreased in the experimental group (P \< 0.05). BDNF level and learning of a speed-accuracy task remained unchanged. Although PFC activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P \< 0.05). An improvement in reaction time during the speed-accuracy task was observed (P \< 0.05). In conclusion, a 6-month combined CR and aerobic exercise intervention improved the psychosocial mental state of overweight and obese women. Although it improved motor planning during the speed-accuracy task, it had little impact on cognition and no effect on brain activity and learning of the speed-accuracy task.


Eligibility criteria: Inclusion Criteria:

* gender: female;
* body mass index (BMI) greater than 25 kg/m2;
* exhibiting weight stability (body weight change \<2 kg) for at least 2 months prior to enrollment;
* sedentary lifestyle (regular exercise 1 h/week).

Exclusion Criteria:

* undergoing lactation;
* pregnant or postmenopausal;
* type 2 diabetes;
* cardiovascular disease.

Primary outcomes:
measure: Weight
timeFrame: baseline
measure: mood state
timeFrame: baseline
measure: Blood brain-derived neurotrophic factor (BDNF)
timeFrame: baseline
measure: Height
timeFrame: baseline
measure: Cognitive functions
timeFrame: baseline
measure: prefrontal cortex activity
timeFrame: baseline
measure: psychomotor function
timeFrame: baseline
Secondary outcomes:
measure: Changes in body weight
timeFrame: 6 months
measure: Changes in mood state
timeFrame: 6 months
measure: changes in blood brain-derived neurotrophic factor (BDNF)
timeFrame: 6 months
measure: Improvement of cognitive functions
timeFrame: 6 months
measure: Changes in prefrontal cortex activity
timeFrame: 6 months
measure: Improvement of psychomotor function
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Laura Zlibinaite
Study officials:
References: