Wuhan Sports University
Wuhan, Hubei, 430000, China
NCT Number: NCT07122271
This observational study aims to investigate whether physical activity (PA) and diet quality (DQ) can reduce depression and mortality risk in individuals with diabetes. Participants will be adults diagnosed with diabetes during the 2007-2018 cycle of the National Health and Nutrition Examination Survey (NHANES). The main questions to be answered include:
Does higher levels of physical activity significantly reduce the risk of depression in individuals with diabetes? Is higher diet quality associated with lower mortality in individuals with diabetes? Investigators will compare individuals with varying levels of PA and DQ to examine whether these two lifestyle factors, both individually and in combination, have protective effects on mental health and survival.
Participants will:
Complete questionnaires regarding their physical activity and dietary intake; Be assessed for depressive symptoms (PHQ-9); Be enrolled in long-term mortality follow-up (from the National Death Index); Analyses will be categorized according to their PA (measured in MET-min/week) and HEI-2015 dietary score.
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Notify Me18 year and older
All sexes
Observational
Wuhan, Hubei, 430000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At the time of baseline NHANES examination for each 2-year survey cycle, including 2007-2008, 2009-2010, 2011-2012, 2013-2014, 2015-2016, and 2017-2018 (6 cycles in total, each lasting 2 years).
Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item self-report instrument scored from 0 to 27. Participants scoring ≥5 will be classified as having depressive symptoms. The outcome is the percentage of participants who meet this criterion at baseline.
Time frame: At the time of baseline NHANES examination for each 2-year survey cycle, including 2007-2008, 2009-2010, 2011-2012, 2013-2014, 2015-2016, and 2017-2018 (6 cycles in total, each lasting 2 years).
Physical activity will be assessed using NHANES physical activity questionnaires and expressed in metabolic equivalent minutes per week (MET-min/week). Participants will be categorized into three PA levels: inactive (<600 MET-min/week), insufficiently active (600-1,199 MET-min/week), and sufficiently active (≥1,200 MET-min/week). Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item self-report instrument scored from 0 to 27, with scores ≥5 indicating the presence of depressive symptoms. Logistic regression models will be used to estimate odds ratios for depression across PA categories, using the inactive group as the reference.Odds Ratio (95% Confidence Interval)
Time frame: At the time of baseline NHANES examination for each 2-year survey cycle, including 2007-2008, 2009-2010, 2011-2012, 2013-2014, 2015-2016, and 2017-2018 (6 cycles in total, each lasting 2 years).
Diet quality will be assessed using the Healthy Eating Index-2015 (HEI-2015) score, derived from two 24-hour dietary recall interviews. Scores range from 0 to 100, with higher scores indicating better diet quality. Participants will be categorized into two groups: unqualified diet quality (HEI-2015 <60) and qualified diet quality (HEI-2015 ≥60). Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item self-report instrument scored from 0 to 27, with scores ≥5 indicating the presence of depressive symptoms. Logistic regression models will be used to estimate odds ratios for depression between diet quality groups, using the unqualified group as the reference.Odds Ratio (95% Confidence Interval)
Time frame: At the time of baseline NHANES examination for each 2-year survey cycle, including 2007-2008, 2009-2010, 2011-2012, 2013-2014, 2015-2016, and 2017-2018 (6 cycles in total, each lasting 2 years).
Physical activity (PA) will be assessed using NHANES physical activity questionnaires and expressed in metabolic equivalent minutes per week (MET-min/week). Diet quality (DQ) will be assessed using the Healthy Eating Index-2015 (HEI-2015) score, derived from two 24-hour dietary recall interviews. Participants will be classified into four PA_DQ groups:
Inactive_Unqualified (PA <600 MET-min/week and HEI-2015 <60) Inactive_Qualified (PA <600 MET-min/week and HEI-2015 ≥60) Active_Unqualified (PA ≥600 MET-min/week and HEI-2015 <60) Active_Qualified (PA ≥600 MET-min/week and HEI-2015 ≥60) Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9), a validated 9-item self-report instrument scored from 0 to 27, with scores ≥5 indicating the presence of depressive symptoms. Logistic regression models will be used to estimate odds ratios for depression across the four PA_DQ groups, using the Inactive_Unqualified group as the reference.Odds Ratio (95% Confidence Interval)
Time frame: From baseline NHANES examination to December 31, 2019 (up to 120 months follow-up)
All-cause mortality will be determined from the NHANES Linked Mortality Files, which are linked to the National Death Index (NDI). Participants will be classified into four combined PA_DQ categories:
Inactive_Unqualified (PA <600 MET-min/week and HEI-2015 <60) Inactive_Qualified (PA <600 MET-min/week and HEI-2015 ≥60) Active_Unqualified (PA ≥600 MET-min/week and HEI-2015 <60) Active_Qualified (PA ≥600 MET-min/week and HEI-2015 ≥60) Subgroup analyses will examine whether hazard ratios for all-cause mortality associated with these PA_DQ categories differ across age (<65 vs ≥65 years), sex, BMI (<29 vs ≥29 kg/m²), and sedentary time (<4 vs ≥4 hours/day). Cox proportional hazards models with interaction terms will be used, and results will be reported as stratified hazard ratios relative to the Inactive_Unqualified group.
Time frame: At the time of baseline NHANES examination for each 2-year survey cycle, including 2007-2008, 2009-2010, 2011-2012, 2013-2014, 2015-2016, and 2017-2018 (6 cycles in total, each lasting 2 years).
Shapley Additive exPlanations (SHAP) analysis will be used to identify and rank the most important predictors of depression risk, defined as Patient Health Questionnaire-9 (PHQ-9) score ≥5. Predictors assessed will include physical activity (PA), diet quality (DQ), body mass index (BMI), education, poverty-income ratio (PIR), age, sex, and sedentary behavior. Results will be reported as variable importance rankings with SHAP values.Relative importance score (SHAP value).
Time frame: At the time of baseline NHANES examination for each 2-year survey cycle, including 2007-2008, 2009-2010, 2011-2012, 2013-2014, 2015-2016, and 2017-2018 (6 cycles in total, each lasting 2 years).
Causal mediation analysis will be used to estimate the indirect effect of body mass index (BMI, kg/m²) on the association between combined physical activity and diet quality (PA_DQ) and depression, defined as Patient Health Questionnaire-9 (PHQ-9) score ≥5. Participants will be classified into four PA_DQ categories:Inactive_Unqualified (PA <600 MET-min/week and HEI-2015 <60),Inactive_Qualified (PA <600 MET-min/week and HEI-2015 ≥60),Active_Unqualified (PA ≥600 MET-min/week and HEI-2015 <60)
,Active_Qualified (PA ≥600 MET-min/week and HEI-2015 ≥60).The outcome will be reported as the average causal mediation effect (ACME) and the proportion mediated (%), using the Inactive_Unqualified group as the reference category.Average Causal Mediation Effect (ACME) and proportion mediated (%)
Minghui Wang
Other
Joint Effects of Physical Activity and Diet Quality on Depression and Mortality in U.S. Adults With Diabetes: A Population-Based Cohort Study Using NHANES 2007-2018 With Mediation and Machine Learning Analyses
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