Obesity, overweight
Conditions
Interventions
Control group:Only provides routine health education and support, without offering the same level of food delivery and individualized intensive management.
Intervention group:Implement a family-based enhanced diet intervention based on the Jiangnan dietary pattern.
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Children: (1) School students in grades 1–4, aged 6–10 years, male or female; (2) Overweight or obese: BMI >= 85th percentile for age and sex; (3) Living together with their biological parents and/or grandparents, with co-residence >= 5 nights per week. 2. Adults: (1) Aged 18–79 years, being the biological parent and/or grandparent of the enrolled child; (2) At least one adult is overweight or obese: BMI 24–35 kg/m^2; (3) No plan for pregnancy within the next 2 years, no history of childbirth in the past year, and not currently breastfeeding. 3. Family as a whole: (1) A three-generation stem family based on direct blood ties, with grandparents, parents, and minor children living together, age range 6–79 years; (2) At least one family member is responsible for cooking and is capable of using a smartphone to record diet and weight, and to communicate online; (3) Able to receive home-delivered food ingredients, have refrigeration equipment, and family members have a habit of eating together; (4) Have Wi-Fi or mobile network access at home, can interact via a smartphone mini-program, and agree to use study-provided devices for weight and physical activity monitoring; (5) Have resided in the study area for at least 6 months and have no plan to move to a non-study area during the intervention period; (6) All family members sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Children: (1) Having diseases requiring long-term medication or special dietary management (e.g., malignancies, diabetes, congenital metabolic disorders, severe cardiovascular diseases, hepatic or renal insufficiency, etc.); (2) Having developmental delay, cognitive impairment, or autism spectrum disorder; (3) Having diseases affecting growth (e.g., genetic/metabolic diseases) or taking medications that affect growth (glucocorticoids, thyroid hormones, growth hormone); (4) Currently having diseases affecting glucose/lipid metabolism (e.g., hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.); (5) Currently having diseases affecting body weight (e.g., malabsorption, functional bowel disease, uncontrolled hyponatremia, eating disorders); (6) Currently taking medications that affect body weight (e.g., thyroid medications, glucocorticoids); (7) Unable to guarantee intervention time, e.g., frequent dining out (=10 meals per week outside home); (8) History of food allergy; (9) Having chronic diseases that affect digestive and absorptive function; (10) Having had an infectious disease within the past month; (11) Other acute diseases supported by clinical evidence that would prevent the implementation of the study intervention; (12) A current diagnosed psychiatric disorder, drug dependence, or a past history thereof; (13) Currently participating in another intervention study or having participated in another drug clinical trial within the past 30 days; (14) Not having signed the informed consent form; (15) Any condition that, in the investigator's judgment, would affect study compliance; (16) Any other condition considered by the physician to preclude participation in the trial. 2. Adults: (1) Diagnosed with type 1 diabetes mellitus, or currently receiving insulin therapy; (2) Currently having other diseases affecting glucose/lipid metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.; (3) Currently having diseases affecting body weight (e.g., malabsorption, functional bowel disease, uncontrolled hyponatremia, eating disorders); (4) Currently taking medications that affect body weight (e.g., thyroid medications, glucocorticoids); (5) Having had a myocardial infarction, acute cerebrovascular event, acute heart failure within the past 6 months, or having been diagnosed with a malignancy within the past 2 years; (6) Severe uncontrolled hypertension, defined as systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg; (7) Unable to guarantee intervention participation time, such as long-term business trips, night-shift work (=2 night shifts per week), or frequent dining out (=10 meals per week outside home); (8) Excessive alcohol consumption: average weekly alcohol intake >140 g for males, >70 g for females; (9) Having communication difficulties such as deafness or dementia, severe psychiatric disorders, or a history of substance abuse; (10) A current diagnosed psychiatric disorder, drug dependence, or a past history thereof; (11) History of food allergy; (12) Having chronic diseases that affect digestive and absorptive function; (13) Having had an infectious disease within the past month (see Appendix 1 of the protocol); (14) Other acute diseases supported by clinical evidence that would prevent the implementation of the study intervention; (15) Currently participating in another intervention study or having participated in another drug clinical trial within the past 30 days; (16) Not having sig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adulte's BMI and child's BMI z-score;Blood pressure;Life essential 8 sco; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum iron;Blood fat;Blood routine examination;Ferritin;Waistline;Quality of life;Height;Glucose metabolism indicators include glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) and fasting insulin (FINS).;Hip circumference;25-hydroxyvitamin D;Hs-CRP;Body composition; | — |
Countries
China
Contacts
Public ContactBi Yufang
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed