NCT07122271

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,621

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
Last Updated

August 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

August 3, 2025

Last Update Submit

August 12, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    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)

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

    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).

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

    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).

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

    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).

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

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

Other Outcomes (2)

  • SHAP Analysis of Key Predictors of Depression Risk in Adults With Diabetes

    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).

  • Mediation Effect of BMI on the Association Between Combined Physical Activity and Diet Quality and Depression in Adults With Diabetes

    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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Sports University

Wuhan, Hubei, 430000, China

Location

Related Links

MeSH Terms

Conditions

Diabetes ComplicationsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Endocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • zeng chen

    Geriatric Hospital of Hainan province

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
120 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 14, 2025

Study Start

March 16, 2025

Primary Completion

June 20, 2025

Study Completion

July 24, 2025

Last Updated

August 14, 2025

Record last verified: 2025-07

Locations