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Diabetes ComplicationsNCT07122271

Joint Effects of Physical Activity and Diet Quality on Depression and Mortality in Diabetes

An observational study of Diabetes Complications and Depression Anxiety Disorder, run by Minghui Wang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
How many people
3,621 participants
Where
1 siteChina
Study dates
16 Mar 2025to 24 Jul 2025
How long will I take part?
120 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study includes adult participants aged 20 years and older with a confirmed diagnosis of diabetes mellitus from the NHANES 2007-2018 dataset. The population comprises individuals with available data on physical activity, diet quality, and depression symptoms, as well as complete demographic and mortality information. Participants represent a nationally representative sample of the non-institutionalized US population. Subgroup analyses were conducted by sex, age group, and BMI category to explore potential effect modification.Machine learning and mediation analysis were also applied to further explore the underlying mechanisms and effect modification.

Who may be able to join

  • Adults aged 20 years and older.
  • Diagnosed with diabetes mellitus, defined by self-report, fasting plasma glucose ≥126 mg/dL, or HbA1c ≥6.5%.
  • Available data on physical activity, diet quality (HEI-2015), and depression status (PHQ-9).
  • Complete demographic and mortality follow-up data.

Who cannot join

  • Missing key exposure or outcome data (e.g., physical activity, HEI-2015, PHQ-9, mortality).
  • Pregnant individuals at the time of the survey.
  • Participants with unreliable or extreme dietary intake data (e.g., energy intake <500 or >5000 kcal/day).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Wuhan Sports University

    Wuhan, Hubei, 430000

Other trials in China

About this study

Official title: 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

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.

Read more

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.

Medical subject headings
Diabetes Complications, Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Adults With Diabetes Meeting Depression Criteria at Baseline (PHQ-9 ≥5)

    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.

    Measured: 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).

Secondary outcomes (4)

  1. Odds Ratio for Depression by Physical Activity Category in Adults With Diabetes

    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)

    Measured: 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).

  2. Odds Ratio for Depression by Diet Quality Category in Adults With Diabetes

    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)

    Measured: 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).

  3. Odds Ratio for Depression by Combined Physical Activity and Diet Quality Categories in Adults With Diabetes

    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)

    Measured: 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).

  4. Subgroup analysis for All-Cause Mortality by Combined Physical Activity and Diet Quality Categories in Adults With Diabetes and Comorbid Depression

    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.

    Measured: From baseline NHANES examination to December 31, 2019 (up to 120 months follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start16 Mar 2025
  3. Primary completion20 Jun 2025
  4. Study completion24 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
3,621 participants (actual)
Target duration
120 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07122271
Sponsor's protocol ID
WuhanSU
Status last verified
Jul 2025
First submitted
3 Aug 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Complications and Depression Anxiety Disorder, run by Minghui Wang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Adults With Diabetes Meeting Depression Criteria at Baseline (PHQ-9 ≥5) (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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07122271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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