Clinical trial NCT07007234: Sedentary Behavior and Depressive Symptoms
Official title: Sedentary Behavior and Depressive Symptoms: Influence of Specific Domains of Sedentary Behavior
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Depressive symptoms are commonly observed in the general population. Individuals with subclinical forms of depression (e.g., not meet the criteria to major depression disorder) are at increased risk of mortality than the general population which is partially explained by the higher incidence of cardiovascular diseases. Currently, the effectiveness of the frontline treatment for depression is not consensual. Further, it also may be expensive for individuals with mild to moderate depression. Sedentary behavior is an independent risk factor for cardiometabolic diseases and mental disorders. However, recent evidence suggests that not all types of sedentary behavior are equally detrimental. For instance, mentally passive sedentary behavior (e.g., watching TV) appear to be detrimental for health outcomes whereas mentally active sedentary behavior (e.g., desk-based office work) appear to offer health benefits. However, more studies are required to determine the magnitude of association between distinct types of sedentary behaviors (e.g., watching TV, listening to music, talking while sitting, sitting around and doing nothing special) with depressive symptoms as well as randomized clinical trials investigating potential benefits of interventions to replace mentally-passive sedentary behaviors with mentally active sedentary behaviors, light physical activity or moderate-to-vigorous activity in individuals with mild to moderate depression. Therefore, the aim of this proposal is to investigate the influence of mentally passive sedentary behavior (i.e., watching TV, listening to music, talking while sitting, sitting around, and doing nothing special) on depressive symptoms. This is a randomized clinical trial. Participants with mild to severe depressive symptoms will be randomly assigned (1:1) into either INTERVENTION or CONTROL group, using a computer-generated randomization code. Depressive symptoms, quality of life, physical activity, sedentary behavior, body composition, and functionality will be assessed at baseline (PRE) and 4 (POST) months after the experimental period. The INTERVENTION group will participate in a 4-month goal-setting intervention aimed to replace mentally passive sedentary behaviors with mentally active sedentary behaviors, light physical activity, or moderate-to-vigorous activity while CONTROL group will receive general instructions related to WHO guidelines for physical activity.


Eligibility criteria: Inclusion Criteria:

* individuals aged over 17 years;
* mild to severe depressive symptoms.

Exclusion Criteria:

* cancer in the past 5 years;
* inability to perform the physical tests;
* prior diagnosis of muscle degenerative disease (e.g., myopathies, amyotrophic lateral sclerosis);

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Secondary outcomes:
measure: Anxiety Symptoms (primary outcome)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Indirect physical activity levels assessment
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Objective physical activity levels assessment
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Indirect sedentary behavior assessment
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Objective sedentary behavior assessment
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Quality of life assessement
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Body Weight
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Fat mass (kg)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Fat-free mass (kg)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Function (30-s Sit-to-stand Test)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
measure: Muscle Function (Timed-up-and-go)
timeFrame: Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Santo Amaro
state: SO
city: Sao Paulo
country: Brazil
facility: University Santo Amaro
state: SP
Study officials:
References: