Obesity during pregnancy Nutritional, Metabolic, Endocrine Obesity during pregnancy
Conditions
Interventions
Participants are randomised to one of two groups in a 1:1 ratio using KCL’s Clinical Trials Unit (CTU) web-based system (www.ctu.co.uk).
Control group: Women allocated to standard care will receive
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women overweight (BMI 25–29.9 kg/m²) or obese (BMI =30 kg/m²) as identified as their first antenatal contact 2. Women with excessive GWG when weighed at 36 weeks gestation, as defined using IoM criteria at risk of postnatal weight retention 3. Aged 18 and over 4. Speak and read English 5. Are expecting a single baby 6. Have not accessed weight management groups in the index pregnancy
Exclusion criteria
Exclusion criteria: 1. <18 years old 2. Insufficient understanding of spoken and written English 3. Current diagnosis of major psychiatric disorder documented 4. Fetus has known abnormality 5. Involvement in another postnatal study 6. Identified medical complications (for example cardiac disease, type 1 diabetes) 7. Identified eating disorders= 8. Previous surgery for weight management 9. Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight is measured at baseline (first antenatal appointment) and 12 months postnatally. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dietary intake is measured using The Dietary Instrument for Nutritional Education (DINE) at baseline (36 weeks gestation), and 6 and 12 months postnatally 2. Physical activity is measured using The International Physical Activity Short-Form’ at baseline (36 weeks gestation), and 6 and 12 months postnatally 3. Mental health is measured using Edinburgh Postnatal Depression Scale 6 and 12 months postnatally 4. Breastfeeding intent, uptake, and duration is measured using questions developed specifically for the study at baseline (36 weeks gestation), and 6 and 12 months postnatally 5. Sleep patterns are measured using using questions developed for the study 6 and 12 months postnatally 6. Smoking status/cigarette dependence is measured at baseline (36 weeks gestation), and 6 and 12 months postnatally 7. Alcohol consumption is measured using Alcohol Use Disorders Identification Test at baseline (36 weeks gestation), and 6 and 12 months postnatally 8. Self-esteem is measured Rosenberg Self-Esteem Scale 6 and 12 months postnatally 9. Infant health is measured questions specifically developed for the study 6 and 12 months postnatally 10. Impact on body image is measured 6 and 12 months postnatally 11. Resource utilisation and costs outcome measures are measured using the EQ-5D-5L and the Adult Service Use Schedule at baseline (36 weeks gestation), and 6 and 12 months postnatally | — |
Countries
England, United Kingdom
Outcome results
None listed