Healthy Habits in Pregnancy and Beyond
Palabras clave
Abstracto
Descripción
The primary objective of the feasibility study is to provide a decision on whether to proceed to a full-scale, multicentre RCT.
The two-arm randomised controlled feasibility study will:
1. Assess the numbers of eligible pregnant women accessing the healthcare services at each partner healthcare site;
2. Assess screening, recruitment and attrition rates;
3. Assess willingness of healthcare staff to recruit women and deliver the HHIPBe intervention as part of routine antenatal clinical care;
4. Assess indicators of engagement with the intervention by women (self-reported logbooks/ app data/ qualitative post-intervention interviews);
5. Assess the acceptability of randomisation to a 'usual care' group and women's views on completion of study measures at each time-point;
6. Assess the acceptability of the intervention to women;
7. Assess fidelity of intervention implementation across each partner site i.e. was HHIPBe delivered as intended;
8. Trial the outcome measures that would be used in a full trial of HHIPBe (and gather data to inform a power calculation for a full trial) including assessment of: GWG, habit-formation and diet and activity behaviours up to 6 weeks postpartum; and health economics measures, alongside an exploration of the potential for data linkage to maternal and neonatal outcomes in each jurisdiction.
fechas
| Verificado por última vez: | 03/31/2020 |
| Primero enviado: | 01/03/2020 |
| Inscripción estimada enviada: | 04/04/2020 |
| Publicado por primera vez: | 04/06/2020 |
| Última actualización enviada: | 04/04/2020 |
| Última actualización publicada: | 04/06/2020 |
| Fecha de inicio real del estudio: | 04/30/2020 |
| Fecha estimada de finalización primaria: | 12/31/2020 |
| Fecha estimada de finalización del estudio: | 03/31/2021 |
Condición o enfermedad
Intervención / tratamiento
Behavioral: Healthy Habits in Pregnancy and Beyond intervention
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Healthy Habits in Pregnancy and Beyond intervention Intervention delivered in early pregnancy during an existing antenatal appointment. 1:1 intervention session (15-20 minutes) with the intervention facilitator (clinician/researcher). Participants provided with a self-guided leaflet for weight management focusing on making 10 simple diet and activity behaviours habitual, including advice on food choice & purchasing, portion size, eating behaviour & keeping active. The tips promote habit formation, nutrition awareness, avoidance of behavioural relapse, and reiterate guidance for pregnant women. Participants provided with a record-keeping logbook and access to an 'app' to self-monitor their weight and behaviours against the 10 target behaviours, during pregnancy and up to 6 weeks postpartum. | Behavioral: Healthy Habits in Pregnancy and Beyond intervention Habit-based intervention to support the development of 10 healthy dietary and activity behaviours for pregnant women with overweight or obesity. |
| No Intervention: Control group The control group will receive 'usual' antenatal care which does not involve routinely delivered specific or standardised dietary advice. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Pregnant Women. - Body Mass Index between ≥25.0 kg/m2 and <38.0 kg/m2. - Primiparous or Multiparous. - Women capable of providing informed consent and of providing consent on behalf of their child. Exclusion Criteria: - Twin or multiple pregnancies. - Insufficient English to understand intervention and written materials. - Nutritional complications i.e. previous or current eating disorder, following a special diet, in receipt of specialist dietary advice. - Pregnancy not viable as determined by the patient's clinical team. - Have been referred to another weight management service by their clinical team during pregnancy that is not part of routine antenatal care. |
Salir
Medidas de resultado primarias
1. Acceptability of the intervention [6 weeks postpartum]
Medidas de resultado secundarias
1. Feasibility of recruitment [During 4 month study recruitment period]
2. Retention rate [End of study - 6 weeks postpartum]
3. Acceptability to healthcare staff [Conducted during the 4 month study recruitment and 5 month intervention delivery periods]
