Type 2 diabetes, chronic kidney disease, musculoskeletal pain, headache, respiratory diseases, dermatological symptoms, depression, malnutrition, cognitive development, diet quality in rural agricultural households Other
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/07/2022: Adults: 1. Household engaged in agriculture work defined as any one or more of the following: owning land, harvesting a crop in the past month regardless of land ownership, or earning a daily wage or contract-based wage for agricultural activities. This includes farmers, farm owners, farm workers, field workers, growers, harvesters, packers, graders and sorters, as well as agricultural pesticide handlers (mixers, loaders, cleaners and sprayers) 2. Aged 18 years and older. Age will be confirmed by directly viewing a government-issued document with the individual’s date of birth 3. Permanently reside in the selected household. ‘Residence’ will be defined as a group of people who eat from the same kitchen 4. Have a child aged 25 years. Age will be confirmed by directly viewing a government-issued document with the individual’s date of birth. 3. Permanently reside in the selected household. ‘Residence’ will be defined as sleeping in the house on a typical weeknight. 4. Have a child aged <3 years who also resides in the household. 5. Willing to provide informed consent. Children: 1. Aged <3 years. Age will be confirmed by directly viewing a government-issued document with the individual’s date of birth. 2. Permanently reside in the selected household. ‘Residence’ will be defined as sleeping in the house on a typical weeknight. 3. Parent or legal guardian willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 20/07/2022: Adults: 1. Plan to move permanently out of the study area in the next 12 months 2. Bedridden or mentally challenged 3. Visible disabilities (e.g., physical malformations, blindness, deafness, obvious genetic syndromes) 4. Primary language other than Telugu 5. Already enrolled in a different research study 6. Unwilling to provide informed consent Children: 1. Bedridden or mentally challenged 2. Visible disabilities (eg, physical malformations, blindness, deafness, obvious genetic syndromes) 3. Already enrolled in a different research study 4. Parent or legal guardian unwilling to provide informed consent Previous exclusion criteria: Adults: 1. Plan to move permanently out of the selected household in the next 12 months 2. Bedridden or mentally challenged 3. Visible disabilities (e.g., physical malformations, blindness, deafness, obvious genetic syndromes) 4. Speak a language other than Telugu 5. Females: pregnant (by self-report) 6. Already enrolled in a different research study 7. Unwilling to provide informed consent Children: 1. Bedridden or mentally challenged 2. Visible disabilities (eg, physical malformations, blindness, deafness, obvious genetic syndromes) 3. Already enrolled in a different research study 4. Parent or legal guardian unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 20/07/2022: Both primary outcomes will be measured at baseline, 12 and 24 months 1. Dialkyl phosphate (DAP) metabolites (dimethylphosphate, dimethylthiophosphate, dimethyldithiophosphate, diethylphosphate, diethylthio-phosphate, and diethyldithiophosphate) in a 15% subset of participants, measured in urine using gas chromatography-mass spectrometry (GC-MS) 2. Dietary diversity measured by 24-hour dietary recall and calculated according to FAO’s Minimum Dietary Diversity for Women (MDD-W) in adults and WHO's dietary diversity score (DDS) in children Previous primary outcome measures: All primary outcomes will be measured at baseline, 12 and 24 months 1. Dialkyl phosphate (DAP) metabolites (dimethylphosphate, dimethylthiophosphate, dimethyldithiophosphate, diethylphosphate, diethylthio-phosphate, and diethyldithiophosphate) measured in urine using gas chromatography-mass spectrometry (GC-MS) 2. Dietary diversity measured by 24-hour dietary recall administered using the Indian adaptation of INTAKE24 and calculated according to FAO’s Minimum Dietary Diversity for Women (MDD-W) 3. Crop yield measured using a questionnaire adapted from the Agriculture Census 2015-16 (Ministry of Agriculture and Farmers’ Welfare) 4. Total household income measured using a questionnaire adapted from the National Sample Survey Office’s (NSS 70th Round) Situation Assessment Survey of Agricultural Households 2013 (Ministry of Statistics and Programme Implementation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/07/2022: All secondary outcomes will be measured at baseline, 12 and 24 months Adults: 1. Glucose measured in fasting plasma samples at a certified laboratory using the Hexokinase method 2. Creatinine and albumin measured in serum at an IDMS traceable laboratory 3. Self-reported clinical symptoms and musculoskeletal pain in the past 3 months. Symptoms will include: itchy skin, rash on skin, dry/cracking skin, blisters on the skin, chest pain, low fever, loss of appetite or body weight, extreme fatigue or weakness, headache, dizziness, eye irritation or watering, pain in the eye, redness in the eye, blurry vision, reduced hearing ability, nasal congestion or runny nose, difficulty breathing, digestive problems, urinate more than usual, and jaundice. The list of symptoms was adapted from a survey on pesticide use in Thailand (Kongtip et al. Int J Environ Res Public Health 2018) 4. Self-reported depressive symptoms measured using the Primary Health Questionnaire (PHQ, 9 items) 5. Women’s empowerment measured using the abbreviated Women’s Empowerment in Agriculture Index (A-WEAI) and abbreviated Women's Empowerment in Nutrition Index (A-WENI) 6. Anaemia measured in venous blood samples at a certified laboratory 7. Household crop yield will be collected via self-report using questions adapted from the Indian National Sample Survey Office’s (NSSO) Situation Assessment Survey of Agricultural Households 8. Household income, expenditures, and debt will be collected via self-report using questions adapted from the NSSO Situation Assessment Survey of Agricultural Households Children: 1. Length (=2 years)/height (>2 years)-for-age z-score measured using a stadiometer and the WHO Child Growth Standards 2. Development measured using the Caregiver-Reported Early Development Index (CREDI) Previous secondary outcome measures: All secondary outcomes will be measured at baseline, 12 and 24 months Adults: 1. Glucose measured in fasting pla | — |
Countries
India