Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000985987
Ethics application status
Approved
Date submitted
13/07/2020
Date registered
30/09/2020
Date last updated
13/10/2022
Date data sharing statement initially provided
30/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Pregnancy Project: Effect of behavioural and lifestyle changes on the amount of weight gain in pregnant women with obesity
Scientific title
Healthy Pregnancy Project: Evaluation of the effect of behavioural and lifestyle changes on the amount of weight gain in pregnant women with obesity
Secondary ID [1] 301705 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pregnancy 318172 0
obesity 318500 0
Condition category
Condition code
Reproductive Health and Childbirth 316188 316188 0 0
Antenatal care
Diet and Nutrition 316504 316504 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a one-on-one, face to face patient- led behaviour change intervention delivered by an experienced and trained Health coach and Endocrinologist at five visits during routine pregnancy care, in the maternity clinic. The first intervention assessment will coincide with the first medical review, usually scheduled between 12-18 weeks. Visit 2 will occur between 20-22 weeks, visit 3 ~ 28 weeks, visit 4 ~32 weeks and visit 5 ~36 weeks. The duration of each intervention session is approximately 20-40 minutes.
The Healthy Pregnancy Clinic is an evidence-based, more intensive program, based on the principles of HeLPher, targeting reproductive-aged non-pregnant women and adapted for pregnancy by the senior authors. It has evidence for efficacy for weight gain prevention and is designed as a low cost pragmatic simple intervention that is incorporated into routine antenatal care. The program focuses on self-management with skills practiced in goal setting/action planning, problem solving and relapse prevention. The intervention content was developed according to evidence-based guidelines including the Institute of Medicine guidelines for gestational weight gain, Australian dietary guidelines for pregnancy and Australian physical activity guidelines. Participants are provided materials on healthy eating from the Australian dietary guidelines from the NHMRC (readily available from https://www.nhmrc.gov.au/about-us/publications/australian-dietary-guidelines#block-views-block-file-attachments-content-block-1). Self-monitoring is encouraged and simple messages on healthy diet and physical activity are provided to mobilise women towards behaviour change, with a personalised approach. Adherence in monitored with an audit of clinical attendance. Participants are not provided with additional support outside of scheduled visits unless specifically required.
Intervention code [1] 318019 0
Prevention
Intervention code [2] 318020 0
Lifestyle
Intervention code [3] 318021 0
Behaviour
Comparator / control treatment
Existing standard of care is used as the comparison intervention. These are the pregnant women attending other collaborative maternity clinics at the hospital. Standard pregnancy care involves provision of written information regarding healthy eating in pregnancy (from the Health Service, provided by the midwife at the first booking visit) and includes recommended recording of weight at the initial booking visit. Control group participants are not provided with written information specifically designed for the study. Regular weighing is recommended to monitor for appropriate weight gain. Women identified with poor or excessive weight gain will be reminded of the need for healthy eating and exercise to assist in their weight management. The standard of care does not require a research representative to supervise the clinic. The total duration of the control intervention is from from the first maternity visit (approximately between 8 and 20 weeks) until birth.
Control group
Active

Outcomes
Primary outcome [1] 324371 0
20% difference in the proportion that exceeded Institute of Medicine guidelines (IOM) gestational weight gain recommendations. The recommended weight gain for a woman who is obese at the onset of pregnant is between 5-9 kg.
Timepoint [1] 324371 0
Total gestational weight gain: the difference between the weight measured at 36 weeks gestation and the weight measured at the first maternity clinic. Weight is measured in the maternity clinic using Wedderburn digital personal scales (model TIHD351), Women are classified into 3 groups according to their final weight gain: weight gain less than recommended, weight within recommended, weight more than recommended,
Primary outcome [2] 324372 0
Total gestational weight gain: the difference between the weight measured at 36 weeks gestation and the weight measured at the first maternity clinic. Weight is measured in the maternity clinic using Wedderburn digital personal scales (model TIHD351),
Timepoint [2] 324372 0
Weight measured at 36 weeks gestation
Secondary outcome [1] 384470 0
Gestational diabetes: A diagnosis for gestational diabetes is made based on the 75g oral glucose tolerance test (OGTT) with one or more of the following values: Fasting plasma glucose equal to or more than 5.1mmol/L. 1-hour post 75g oral glucose load equal to or more than 10.0 mmol/L. 2-hour post 75g oral glucose load equal to or more than 8.5 mmol/L.
Timepoint [1] 384470 0
This test can be performed at 26-28 weeks gestation, or earlier, at the clinicians discretion
Secondary outcome [2] 384471 0
Gestational diabetes requiring insulin use, as assessed by participant's medical record of gestational diabetes and prescription of insulin use, etc
Timepoint [2] 384471 0
Insulin use requirement can be at any timepoint during pregnancy
Secondary outcome [3] 384472 0
Induction of labour, assessed by participant's medical record of delivery
Timepoint [3] 384472 0
Induction of labour at birth, assessed by participant's medical record of delivery
Secondary outcome [4] 384473 0
Caesarean delivery assessed by participant's medical record of delivery,
Timepoint [4] 384473 0
At birth, the gestation is at the clinician's discretion
Secondary outcome [5] 384474 0
Hypertensive disorders of pregnancy includes a composite of 3:
1. pregnancy induced-hypertension (new onset of hypertension diagnosed after 20 weeks gestation, assessed by a sphygmomanometer reading of blood pressure of greater than or equal to 140 mmHg systolic and/or greater than or equal to 90 mmHg diastolic)
2. pre-eclampsia
3. eclampsia
Timepoint [5] 384474 0
Hypertensive disorders of pregnancy includes a composite of 3:
1. pregnancy induced-hypertension: new onset of hypertension diagnosed after 20 weeks gestation (systolic BP greater than or equal to 140 or diastolic greater than or equal to 90 mm Hg
2. pre-eclampsia: development of hypertension and proteinuria after 20 weeks gestation
3. eclampsia: development of convulsions in a preexisting pre-eclampsia or it may appear unexpectedly in a patient with minimally elevated blood pressure and no proteinuria
Secondary outcome [6] 384475 0
Preterm birth assessed by participant's medical record of delivery
Timepoint [6] 384475 0
before 37 completed weeks of gestation
Secondary outcome [7] 384476 0
birthweight (grams) measured by digital scale
Timepoint [7] 384476 0
at birth
Secondary outcome [8] 384477 0
small for gestational age, assessed by birthweight being below the 10th percentile for babies of the same gestational age and sex, using Australian national birthweight percentiles.
Timepoint [8] 384477 0
at birth
Secondary outcome [9] 384478 0
large for gestational age, assessed by birthweight being above the 90th percentile for babies of the same gestational age and sex, using Australian national birthweight percentiles.
Timepoint [9] 384478 0
at birth
Secondary outcome [10] 414717 0
Program implementation and generalisability learnings will be evaluated using The RE-AIM evaluation framework (Reach, effectiveness, adoption, implementation and maintenance).

More detail provided in this table:
Evaluation of Healthy Pregnancy Project using criteria developed by RE-AIM (1)

REACH Items to be evaluated (yes, no, N/A)
A. Participant exclusion criteria (% excluded) yes
B. Percentage who participate yes
C. Participants characteristics vs. nonparticipants yes
D. Qualitative methods N/A
EFFICACY
A. Primary outcome measures yes
B. Measure of broader outcome measures Other maternal and neonatal outcomes
yes
C. Robustness across subgroups yes
D. Attrition (%) yes
E. Qualitative methods A mixed methods evaluation of participants evaluated facilitators and barriers to program effectiveness (2)

ADOPTION (staff level)
A. Qualitative methods A qualitative evaluation of health professionals evaluated facilitators and barriers to participation (3)

IMPLEMENTATION
A. % of full delivery or full calls Yes
Fidelity and adherence will be evaluated
B. Program adaptions yes
C. Consistency of researchers, time and setting yes
D. Qualitative methods applied Program implementation was explored at participant and health professional level with high program acceptability (2)

MAINTENANCE (setting)
A. Program continuation 6 months post study completion The program has continued for more than two year post data completion and is still ongoing
B. How program was adapted The program continues in the same form, using telehealth since covid 19
C. Use of qualitative methods to understand setting level institutionalisation Interviews with health professionals and participants explored improving the service for program continuation (2, 3)

In order to assess this new outcome, data is collected in a variety of ways:
- semi structured interviews with participants and health professionals
- questionnaires completed by participants
- used of templates by clinicians to ensure consistency of delivery

References

1. Kessler RS, Purcell EP, Glasgow RE, Klesges LM, Benkeser RM, Peek CJ. What does it mean to "employ" the RE-AIM model? Eval Health Prof. 2013;36(1):44-66.
2. Goldstein RF, Boyle J, A., Clement L, Teede HJ, Harrison CL. Facilitators and Barriers to behaviour change within a lifestyle program for women with obesity to prevent excess gestational weight gain: A mixed methods evaluation. BMC Pregnancy and Childbirth. 2021.
3. Goldstein RF, Walker RE, Teede HJ, Harrison CL, Boyle JA. The Healthy Pregnancy Service to optimise excess gestational weight gain for women with obesity: A qualitative study of health professionals’ perspectives Journal of Clinical Medicine. 2020;doi:10.3390(9 (12)).
Timepoint [10] 414717 0
This process will be completed by June 2023

Eligibility
Key inclusion criteria
Women with a pre-pregnancy BMI of 35- 43 kg/m² are eligible for inclusion. Women are eligible if they are aged over 18 years, have a singleton pregnancy and no chronic medical conditions requiring specific care during pregnancy, and their first midwife appointment was before the end of the 23rd week of gestation.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study was designed to have 80% power to detect between-group difference of 20% in the primary outcome, with a two-tailed alpha level of 0.05. Power calculation was based on the proportion of women exceeding IOM weight recommendations, analysis of interventions in gestational weight gain reporting a reduction in excess gestational weight gain, and the rate of eligible women attending the maternity clinic,. This corresponded to approximately 240 women, 160 in the intervention, 80 in standard care. For second primary outcome of total gestational weight gain, we can detect a minimum difference of 1.42 kg between groups with a sample size of 912 (608 in intervention, and 304 controls) assuming power of 0.8, alpha of 0.05, two-sided hypothesis and standard deviation of 7.21 estimated from the studies in a systematic of interventions

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
12/12/2022
Actual
Date of last data collection
Anticipated
12/04/2023
Actual
Sample size
Target
1000
Accrual to date
600
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17038 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 30707 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 306141 0
University
Name [1] 306141 0
Monash University
Country [1] 306141 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash Centre for Health Research and Implementation, Level 1, 43-51 Kanooka Gve Clayton 3168, Victoria
Country
Australia
Secondary sponsor category [1] 306610 0
None
Name [1] 306610 0
None
Address [1] 306610 0
None
Country [1] 306610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306358 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 306358 0
Ethics committee country [1] 306358 0
Australia
Date submitted for ethics approval [1] 306358 0
27/01/2015
Approval date [1] 306358 0
28/07/2015
Ethics approval number [1] 306358 0
RES-17-0000-313L

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103606 0
Prof Helena Teede
Address 103606 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Gve Clayton 3168 VIC
Country 103606 0
Australia
Phone 103606 0
+613 85722644
Fax 103606 0
Email 103606 0
[email protected]
Contact person for public queries
Name 103607 0
Rebecca Goldstein
Address 103607 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Gve Clayton 3168 VIC
Country 103607 0
Australia
Phone 103607 0
+61 409239539
Fax 103607 0
Email 103607 0
[email protected]
Contact person for scientific queries
Name 103608 0
Helena Teede
Address 103608 0
Monash Centre for Health Research and Implementation
Level 1, 43-51 Kanooka Gve Clayton 3168 VIC
Country 103608 0
Australia
Phone 103608 0
+613 85722644
Fax 103608 0
Email 103608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval for this


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFacilitators and barriers to behaviour change within a lifestyle program for women with obesity to prevent excess gestational weight gain: a mixed methods evaluation.2021https://dx.doi.org/10.1186/s12884-021-04034-7
N.B. These documents automatically identified may not have been verified by the study sponsor.