Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial

Lucilla Poston; Annette L Briley; Suzanne Barr; Ruth Bell; Helen Croker; Kirstie Coxon; Holly N Essex; Claire Hunt; Louise Hayes; Louise M Howard; Nina Khazaezadeh; Tarja Kinnunen; Scott M Nelson; Eugene Oteng-Ntim; Stephen C Robson; Naveed Sattar; Paul T Seed; Jane Wardle; Thomas Ab Sanders; Jane Sandall

doi:10.1186/1471-2393-13-148

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial

Lucilla Poston^*, Annette L Briley, Suzanne Barr, Ruth Bell, Helen Croker, Kirstie Coxon, Holly N Essex, Claire Hunt, Louise Hayes, Louise M Howard, Nina Khazaezadeh, Tarja Kinnunen, Scott M Nelson, Eugene Oteng-Ntim, Stephen C Robson, Naveed Sattar, Paul T Seed, Jane Wardle, Thomas Ab Sanders, Jane Sandall

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

112 Citations (Scopus)

Abstract

Background: Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.

Methods: We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m(2)). Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and questionnaire, at 16(+0) to 18(+6) and at 27(+0) to 28(+6) weeks' gestation in women in control and intervention arms. Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken. The full RCT protocol was undertaken to assess feasibility.

Results: Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p <0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.

Conclusions: This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.

Trial registration: Trial Registration Number: ISRCTN89971375

Original language	English
Article number	148
Number of pages	16
Journal	Bmc pregnancy and childbirth
Volume	13
DOIs	https://doi.org/10.1186/1471-2393-13-148
Publication status	Published - 15 Jul 2013

Keywords

Pregnancy
Obesity
Diet
Physical activity
Complex intervention
Evaluation
GESTATIONAL WEIGHT-GAIN
MEASURED PHYSICAL-ACTIVITY
LIFE-STYLE INTERVENTION
GLYCEMIC INDEX
INSULIN SENSITIVITY
ENERGY-EXPENDITURE
MATERNAL OBESITY
RISK
METAANALYSIS
OVERWEIGHT

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Poston, L., Briley, A. L., Barr, S., Bell, R., Croker, H., Coxon, K., Essex, H. N., Hunt, C., Hayes, L., Howard, L. M., Khazaezadeh, N., Kinnunen, T., Nelson, S. M., Oteng-Ntim, E., Robson, S. C., Sattar, N., Seed, P. T., Wardle, J., Sanders, T. A., & Sandall, J. (2013). Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial. Bmc pregnancy and childbirth, 13, Article 148. https://doi.org/10.1186/1471-2393-13-148

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title = "Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial",

abstract = "Background: Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.Methods: We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m(2)). Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and questionnaire, at 16(+0) to 18(+6) and at 27(+0) to 28(+6) weeks' gestation in women in control and intervention arms. Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken. The full RCT protocol was undertaken to assess feasibility.Results: Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p <0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.Conclusions: This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.Trial registration: Trial Registration Number: ISRCTN89971375",

keywords = "Pregnancy, Obesity, Diet, Physical activity, Complex intervention, Evaluation, GESTATIONAL WEIGHT-GAIN, MEASURED PHYSICAL-ACTIVITY, LIFE-STYLE INTERVENTION, GLYCEMIC INDEX, INSULIN SENSITIVITY, ENERGY-EXPENDITURE, MATERNAL OBESITY, RISK, METAANALYSIS, OVERWEIGHT",

author = "Lucilla Poston and Briley, {Annette L} and Suzanne Barr and Ruth Bell and Helen Croker and Kirstie Coxon and Essex, {Holly N} and Claire Hunt and Louise Hayes and Howard, {Louise M} and Nina Khazaezadeh and Tarja Kinnunen and Nelson, {Scott M} and Eugene Oteng-Ntim and Robson, {Stephen C} and Naveed Sattar and Seed, {Paul T} and Jane Wardle and Sanders, {Thomas Ab} and Jane Sandall",

year = "2013",

month = jul,

day = "15",

doi = "10.1186/1471-2393-13-148",

language = "English",

volume = "13",

journal = "Bmc pregnancy and childbirth",

issn = "1471-2393",

publisher = "BioMed Central",

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Poston, L , Briley, AL , Barr, S, Bell, R, Croker, H, Coxon, K, Essex, HN, Hunt, C, Hayes, L, Howard, LM, Khazaezadeh, N, Kinnunen, T, Nelson, SM, Oteng-Ntim, E, Robson, SC, Sattar, N, Seed, PT, Wardle, J, Sanders, TA & Sandall, J 2013, 'Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial', Bmc pregnancy and childbirth, vol. 13, 148. https://doi.org/10.1186/1471-2393-13-148

Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial. / Poston, Lucilla ; Briley, Annette L ; Barr, Suzanne et al.
In: Bmc pregnancy and childbirth, Vol. 13, 148, 15.07.2013.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial

AU - Poston, Lucilla

AU - Briley, Annette L

AU - Barr, Suzanne

AU - Bell, Ruth

AU - Croker, Helen

AU - Coxon, Kirstie

AU - Essex, Holly N

AU - Hunt, Claire

AU - Hayes, Louise

AU - Howard, Louise M

AU - Khazaezadeh, Nina

AU - Kinnunen, Tarja

AU - Nelson, Scott M

AU - Oteng-Ntim, Eugene

AU - Robson, Stephen C

AU - Sattar, Naveed

AU - Seed, Paul T

AU - Wardle, Jane

AU - Sanders, Thomas Ab

AU - Sandall, Jane

PY - 2013/7/15

Y1 - 2013/7/15

N2 - Background: Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.Methods: We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m(2)). Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and questionnaire, at 16(+0) to 18(+6) and at 27(+0) to 28(+6) weeks' gestation in women in control and intervention arms. Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken. The full RCT protocol was undertaken to assess feasibility.Results: Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p <0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.Conclusions: This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.Trial registration: Trial Registration Number: ISRCTN89971375

AB - Background: Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity.Methods: We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m(2)). Diet was assessed by repeated triple pass 24-hour dietary recall and physical activity by accelerometry and questionnaire, at 16(+0) to 18(+6) and at 27(+0) to 28(+6) weeks' gestation in women in control and intervention arms. Attitudes to behaviour change and quality of life were assessed and a process evaluation undertaken. The full RCT protocol was undertaken to assess feasibility.Results: Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p <0.001) and saturated fat intake (-1.6% energy, 95% CI -2.8 to -0. 3) at 28 weeks' gestation. Objectively measured physical activity did not change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery.Conclusions: This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT.Trial registration: Trial Registration Number: ISRCTN89971375

KW - Pregnancy

KW - Obesity

KW - Diet

KW - Physical activity

KW - Complex intervention

KW - Evaluation

KW - GESTATIONAL WEIGHT-GAIN

KW - MEASURED PHYSICAL-ACTIVITY

KW - LIFE-STYLE INTERVENTION

KW - GLYCEMIC INDEX

KW - INSULIN SENSITIVITY

KW - ENERGY-EXPENDITURE

KW - MATERNAL OBESITY

KW - RISK

KW - METAANALYSIS

KW - OVERWEIGHT

U2 - 10.1186/1471-2393-13-148

DO - 10.1186/1471-2393-13-148

M3 - Article

C2 - 23855708

SN - 1471-2393

VL - 13

JO - Bmc pregnancy and childbirth

JF - Bmc pregnancy and childbirth

M1 - 148

ER -