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Trial registered on ANZCTR

Registration number

ACTRN12611000064909

Ethics application status

Approved

Date submitted

17/12/2010

Date registered

18/01/2011

Date last updated

23/09/2024

Date data sharing statement initially provided

23/09/2024

Date results provided

23/09/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

The ’40-Something’ Study: Preventing weight gain prior to menopause

Scientific title

The ’40-Something’ Study: A pilot weight control randomised controlled trial for healthy weight and overweight mid-age pre-menopausal women.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1118-1612

Trial acronym

nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Weight gain

Abdominal Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Equal numbers of healthy weight (BMI of 18.5-24.9kg/m2) and overweight (BMI 25-29.9kg/m2 ) women (44-50 years and still pre-menopausal) will be recruited and randomly allocated to an Intensive Intervention group (4 individual sessions with a Dietitian and 1 with an Exercise Physiologist) or to an Information Only control group over a 12 month period.
1. Intensive Intervention participants:
Each intensive intervention participant will each have five consultations with a health professional (4 with a Dietitian and 1 with an Exercise Physiologist) who will be registered Medicare providers. The professionals will be trained to promote changes in dietary intake and physical activity (PA) in order to achieve weight control goals using a written protocol, developed by researchers using Clinical Best Practice Weight Management Guidelines and principles of motivational interviewing (see point 2 for detail). The women will be provided with print materials as detailed below.
Appointment 1-(baseline) 60 minutes with Dietitian: Discuss current weight and set weight maintenance/loss goals. Assess motivation levels. Provide dietary advice to consume a high nutritional quality diet providing around 8300kJ/6300kJ per day. Use a social cognitive framework to identify environmental barriers and find strategies to overcome them by increasing self efficacy. Provide pamphlet: ‘Weight control: how to maintain your weight as you approach menopause’ to healthy weight women or ‘Weight control: how to lose weight as you approach menopause’ to those overweight at baseline.
Appointment 2- (baseline) 60 minutes with Exercise Physiologist: Discuss current PA levels and exercise experience. Conduct pre-exercise screening, assess injury history and determine exercise self efficacy. Evaluate compliance with current guidelines (150 mins/wk for healthy weight and 250mins/wk for overweight women as well as less than 3 hours/day sitting time) and discuss barriers and facilitators. Set goals for lifestyle PA (monitored by pedometers) and provide individualised exercise training program consisting of progressive resistance training and aerobic activity.
Appointment 3 (3 months) 45 minute appointment with Dietitian: Check weight and discuss any weight change. Provide weight maintenance advice for overweight women reaching goal weight. Assess motivation. Discuss compliance with dietary advice using 4 day food record and pedometer data and discuss any barriers arising.
Appointment 4 (6 months) 45 minute appointment with Dietitian: Check weight and discuss any weight change. Assess motivation. Discuss any barriers arising.
Appointment 5 with Dietitian (9 months) 45 minute appointment with Dietitian: As per appointments 3 and 4 months, plus provide further weight maintenance advice. Advise how to stay motivated. Provide contact details for any queries.
2. Motivational interviewing (MI)
Motivational interviewing techniques will be used by the practitioners DURING the interviews. this is not additional to the procedures described- it is the PROCESS that will be used. MI is used as an approach where the weight change goals and behaviour changes for dietary intake and physical activity are suggested by the client to promote autonomy. The dietitian and exercise physiologist faciltate this process. Participants are encouraged to take responsibility for their own changes. The communication style on the part of the participants is non-directive; it is questioning, reflective and affirming. The interviews will be audio-recorded, and evaluated by an experienced psychologist for compliance with MI techniques.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

Information Only control group
The control group women will receive written materials to prevent attrition from demoralisation. The materials will be identical to those provided to the intervention women. the only difference is that the control group women will receive the materials by mail while the intervention group women received them face to face.
Women who are healthy weight at baseline will receive materials on how to achieve an energy intake of 8300kJ/day and 150 min/week physical activity in the pamphlet: ‘Weight control: how to maintain your weight as you approach menopause’

Women who are overweight at baseline will receive materials detailing how to achieve an energy intake of 6300kJ/day and 250min/week of physical activity in the pamphlet: ‘Weight control: how to lose weight as you approach menopause’.

Control group

Active

Outcomes

Primary outcome [1]

1. Body weight (kg) measured in light clothing, without shoes on a digital scale to the nearest 0.01 decimal, using Omron HBR-500 Body Composition Scales (Omron Healthcare Co. Ltd. Japan).

Timepoint [1]

Baseline, 3 months and 12 months after commencing intervention to assess intervention effects, then 18 and 24 months after intervention commencement to assess maintenance.

Primary outcome [2]

2. Waist Circumference (cm) - Waist circumference measured at the narrowest point. Each measurement will be recorded with a non-extensible steel tape (KDSF10-02, KDS Corporation, Osaka, Japan).

Timepoint [2]

Baseline, 3 months and 12 months after commencing intervention to assess intervention effects, then at 24 months after intervention commencement to assess maintenance.

Secondary outcome [1]

1. Body Mass Index (BMI) - Height will be measured to 0.1 cm using the stretch stature method and a stadiometer (Veeder-Root (VR) High Speed Counter) (Harpenden/Holtain, Mentone Education Centre, Morrabin, Victoria). BMI will be calculated using the standard equation (weight [kg]/height[m]2).

Timepoint [1]

Baseline, 3 months and 12 months after commencing intervention to assess intervention effects, then at 18 and 24 months after intervention commencement to assess maintenance.

Secondary outcome [2]

2. Systolic and diastolic blood pressure and resting heart rate will be measured using a NISSEI/DS-105E digital electronic blood pressure monitor (Nihon Seimitsu Sokki Co. Ltd., Gunma, Japan) under standardized procedures

Timepoint [2]

Baseline, 3 months and 12 months after commencing intervention to assess intervention effects, then at 24 months after intervention commencement to assess maintenance.

Secondary outcome [3]

3. Physical activity measured using Yamax SW700 pedometers (Yamax Corporation, Kumamoto City, Japan). Participants will be asked to wear pedometers for four consecutive days and keep to their normal routine. At baseline assessments, participants will be instructed on how to attach the pedometers (at the waist on the right hand side) and asked to remove the pedometers only when sleeping, when the pedometer might get wet (e.g. swimming, showering) or during contact sports. At the end of the day participants were instructed to record their steps and reset their pedometers to zero. Once they had completed four days of monitoring, participants will be instructed to return it to the research team.

Timepoint [3]

Participants will wear pedometers for 4 days at baseline and then again at 3 and 12 months after beginning the intervention.

Secondary outcome [4]

4. 4 day Weighed Food Record (WFR)
Dietary intake will be measured through a 4 day WFR. Participants will be trained how to accurately complete the diary according to a developed protocol. The women will be instructed to complete the WFR over 4 consecutive days, including one weekend day (Wednesday to Saturday or Sunday to Wednesday). Participants will be provided with electronic kitchen scales sensitive to 0.1 decimal points (Salter Electronic Kitchen Scale; Salter Housewares Tonbridge England) to record the weight, in grams, of all food, beverages and leftovers at the time of consumption. They will be given the booklet ?Your diet and physical activity diary? for the purpose of recording the information. Detailed descriptions of foods are requested, including the brands of packaged foods, alcohol, water, snacks and cooking methods. Participants are encouraged not to change usual eating habits whilst completing the diary.

Timepoint [4]

Measured at baseline, 3 months and 12 months after beginning the intervention

Secondary outcome [5]

5. Food portion sizes will be assessed using items from the Cancer Council Victoria (CCV) Dietary Questionnaire for Epidemiological Studies (DQES v2)

Timepoint [5]

Measured at baseline and 12 months after beginning the intervention

Secondary outcome [6]

6. Physical activity and dietary restraint using validated questionnaires

Timepoint [6]

Baseline, 3 months and 12 months after commencing intervention to assess intervention effects, then at 24 months after intervention commencement to assess maintenance.

Secondary outcome [7]

7. Perceived physical and mental health using the Short Form 36 (SF-36) questionnaire

Timepoint [7]

Baseline and 12 months after commencing intervention to assess intervention effects, then at 24 months after intervention commencement to assess maintenance.

Secondary outcome [8]

8. Percentage Fat, Skeletal Muscle mass and resting metabolic rate using BIA Omron HBR-500 Body Composition Scales (Omron Healthcare Co. Ltd. Japan). scales

Timepoint [8]

Baseline, 3 months and 12 months after commencing intervention to assess intervention effects, then at 18 and 24 months after intervention commencement to assess maintenance.

Secondary outcome [9]

9. Sedentary behaviours: will be assessed by a validated questionnaire from Brown et al. Medicine and Science in Sports and Exercise (MSSE) (in press)Timepoint: Measured at baseline and 12 months after beginning the intervention

Timepoint [9]

Baseline and 12 months after commencing intervention to assess intervention effects, then at 24 months after intervention commencement to assess maintenance.

Secondary outcome [10]

10. Demographics and socio-economic status. A questionnaire will obtain demographic information e.g. age, ethnicity, marital status, language spoken at home, income and postcode

Timepoint [10]

Measured at baseline

Secondary outcome [11]

11. A process evaluation will be performed with a questionnaire to participants examining issues including study feasibility, participant satisfaction and suggestions for improvement.

Timepoint [11]

measured 12 months after commencing intervention

Eligibility

Key inclusion criteria

Inclusion Criteria:
1. women 44 to 50 years of age
2. have had a menstrual period in the preceding 3 months
3. able to attend appointments in Newcastle
4. baseline Body Mass Index 18.5 to 29.9kg/m2
5. Women who have not had a hysterectomy or oophorectomy
6. Women without seriously medical conditions such as heart disease, Type 1 and 2 diabetes
7. Not pregnant
8. Women who can read write and understand English

Minimum age

44 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Males
2. women no longer experiencing periods
3. women younger than 44 or older than 50 years of age
4. women who have had a hysterectomy
5. Women with Body Mass Index (BMI) of less than18.5 kg/m2 (Underweight) or above 29.9 kg/m2 (Obese). The rationale for these exclusions are based on incompatible goals i.e. the underweight need to gain weight, rather than prevent weight gain, while the obese need to lose at least 10% of body weight, which is outside the scope of the modest weight loss goals for the overweight women (7% or less).

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

54 women will be recruited by advertising via the University media Unit through radio, TV, newspapers, University Website and online media. After confirming they meet eligibility criteria, potential participants will be provided with a written Information Statement about the study to read prior to signing a consent form.

Once recruited, women attend the University for the baseline measures detailed in questions 12 and 13. The random number sequence generated by the statistician (see next point) were printed on sheets of paper, and numbers were allocated by CI1 as each participant registered to attend the baseline measures. Only one researcher (the Intervention Dietitian) had a copy of the key to which numbers were intervention and which were control. After the baseline measures the intervention Dietitian contacts the women by telephone to reveal their allocation. Only the dietitian completing the intervention appointments is aware of the allocation condition, and all researchers are unaware of the allocation at the time of the baseline measurements.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Subjects will be randomly allocated to one of two groups using a randomised block design. The random allocation sequence has been generated by the study statistician, using a computer-based random number-producing algorithm in block lengths of six to ensure an equal chance of allocation to each group. Randomisation will be done with the Plan procedure ( Proc Plan) in the SAS statistical software package. The numbers are allocated as described above.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample Size: The sample size calculation was based on the main outcome measure of body weight. Observational studies of women in this age group in the Australian population have demonstrated a mean (SD) weight gain of 1.04 (4.7) kg over a two-year period. Given both intervention groups were comprised of equal numbers of healthy weight and overweight women and presuming the overweight women would meet the intervention goal of losing 5 kg in the first 12 months and the healthy weight women would show zero weight change, the net weight change should be a 2.5 kg weight loss in the MI group by the end of phase 1. Based on the Australian data of net weight gain in the general population of mid-age women managing their weight by self-directed means [Williams et al, IJO; 2007, 31(6)978-986] we would expect a mean (SD) net weight gain of 0.5 (4.7) kg per year in our SDI (control) group. This would give an expected difference between the two groups of 3.0 kg after 12 months (end phase 1) and 3.5 kg after 24 months (end phase 2). Assuming equal sample sizes, to detect a difference in weight between groups of 3.5 kg with 80% power and a significance level of 0.05, a sample size of 22 women was required for each group. Allowing for an attrition rate of 20% by the end of 24 months, a total sample size of 55 women is required.
Statistical analyses
Outcome measures collected at baseline will be compared to those at 12 months (after adjusting for baseline weight) to assess intervention effects and compared with measures at 24 months (end phase 2) to assess whether the intervention effects were maintained. Analyses will be conducted using the intention to treat principle, and performed using SPSS version 19 (IBM). All variables will be checked for plausibility. Continuous variables will be assessed for normality. Independent sample t-tests and chi-squared tests will be conducted on continuous and categorical variables (respectively) to check they do not vary by intervention group at baseline, and by completers versus attriters. Analysis of covariance will be used to examine whether the intervention groups differed significantly in weight at each of 12 and 24 months after adjusting for baseline weight. Behaviour changes in diet and physical activity will be assessed as secondary outcome measures using analysis of covariance to determine whether the MI and SDI groups differed significantly in dietary or physical activity behaviours at 12 months. Results will be stratified for baseline BMI category.
Logistic regression analysis will be performed to assess whether categorical variables, such as smoking status significantly influenced weight. The visceral adipose tissue variable will be assessed for between group differences at 12 and 24 months using independent sample t-tests, and analyses stratified by BMI category to determine whether the results differed for the healthy weight and overweight women. Sensitivity analyses will be conducted to determine the effects on the outcomes of different methods of treating loss to follow-up (last observation carried forward versus imputation). The relationship between weight outcomes and compliance with the diet and physical activity behaviours will be assessed using mediation analysis [55].
A per protocol analysis will be conducted on women who adhered to the requirements of their assigned group. Adherent women are defined as those who completed all required eating and physical activity diaries over the 12-month period and attended all assessment sessions, regardless of assigned group, and who attended all five health professional consultations for the MI group. Results of the protocol adherent group will be compared with non-adherers in each group, that is, those who did not meet the adherence recommendations.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

25/05/2010

Actual

25/05/2010

Date of last participant enrolment

Anticipated

Actual

29/06/2010

Date of last data collection

Anticipated

Actual

31/08/2012

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Newcastle

Address [1]

University of Newcastle
Callaghan
NSW 2308

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Lauren Williams, University of Canberra

Address

School of Health Sciences Faculty of Health University of Newcastle Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Clare Collins

Address [1]

School of Health Sciences
Faculty of Health
University of Newcastle
Callaghan
NSW 2308

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Associate Professor Philip Morgan

Address [2]

School of Education
Faculty of Education and Arts
University of Newcastle
Callaghan
NSW 2308

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

University of Newcastle
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/04/2010

Ethics approval number [1]

H- 2010-0030

Summary

Brief summary

BACKGROUND AND AIMS
Middle age (45-54y), when most women experience menopause, is a particularly high risk stage for weight gain in women, and more than half the women in this age group are overweight or obese. Post-menopause is characterised by the absence of oestrogen resulting in abdominal deposition of body fat and subsequent development or exacerbation of metabolic syndrome. An estimated 48% of coronary events in women are attributable to metabolic syndrome, and risk of cardiovascular disease significantly increases after menopause. There is some evidence that intervention can prevent or minimise the body composition changes leading to post-menopausal obesity, making the years immediately prior to menopause a key stage for intervention. Despite the increased health risks associated with menopausal weight gain, no Australian interventions have been developed for this target group. 

A potential model for intervention exists within the Enhanced Primary Care (EPC) scheme of Medicare (funding of 5 Allied Health visits for those referred by a GP with chronic and complex problems). This model could be extended to the target group of women in the years immediately prior to menopause.

The aim of this randomised control trial (the 40-Something Study) is to pilot test the feasibility of applying this model to the prevention of weight gain in non-obese women aged 44-50. Given the RCT will be a pilot of what will hopefully be a wider intervention, it will particularly assess the feasibility of recruiting into the study, ability to retain participants and will test the intervention and information only materials. 

RESEARCH PLAN
The study has been designed to adhere to the CONSORT guidelines. An RCT design is being used to test the ability of a 12 month intensive intervention (four Dietitian appointments and one Exercise Physiologist appointment using motivational interviewing to advise on dietary and physical activity strategies) to prevent weight gain, in comparison to the provision of written information. Women were invited to participate if they were between 44 and 50y, still menstruating, BMI 18.5- 29.9 and able to attend appointments in Newcastle, NSW. 

Those in the healthy weight range (18.5-24.9kg/m2) at baseline will be given the goal of maintaining weight within 1kg, and provided with weight maintenance advice, (8300kJ/day, and at least 150 mins/week of PA). Women in the overweight range (25-29.9 kg/m2) at baseline will be advised to lose at least 7% of body weight, (by following a 6300kJ/day regime and 250 mins/wk of PA) before being given weight maintenance advice. After baseline data was collected the women were randomly allocated to intervention or control groups. All researchers except the Dietitian conducting the appointments with the intervention group will remain blind to the allocation condition.

The primary outcome measures are weight and waist circumference, with secondary measures of biomarkers of metabolic syndrome. Baseline data has been collected on anthropometry, biomarkers of metabolic syndrome, and behaviours influencing weight gain including dietary intake, physical activity and dietary restraint, in addition to health and demographic data.  The data will be collected again at 12 months after the intervention commenced. Compliance to the interventions in terms of dietary intake and PA is being measured 3 months after commencing the intervention. 

The study involves a comparison of a baseline measurement to a single follow-up measure to assess the success of the intervention (baseline to 12 months). Paired t-tests will be used to determine if there is a significant change in weight for each group with sub-analyses for those normal weight and overweight at baseline. Repeated measures analysis of covariance will be used to examine whether the groups (control and intervention) differ significantly on the amount of weight change between baseline and follow up. 

The project will be monitored by a Management Committee (meeting at least monthly) to oversee project implementation.

Trial website

n/a

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Lauren Williams

Address

Nutrition and Dietetics
Level 2, G40 Building
Griffith University
Gold Coast Campus
Parkville QLD 4222.

Country

Australia

Phone

+61 417028371

Fax

Lauren.williams@griffith.edu.au

Contact person for public queries

Name

Prof Lauren Williams

Address

School of Health Sciences
Griffith University
QLD 4222

Country

Australia

Phone

+61 7 56780155

Fax

+61 2 4921 7053

lauren.williams@griffith.edu.au

Contact person for scientific queries

Name

Prof Lauren Williams

Address

as above

Country

Australia

Phone

+61 2 6206 8709

Fax

+61 2 4921 7053

lauren.williams@griffith.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Can a relatively low-intensity intervention by health professionals prevent weight gain in mid-age women? 12-month outcomes of the 40-something randomised controlled trial.	2014	https://dx.doi.org/10.1038/nutd.2014.12
Embase	Maintaining the outcomes of a successful weight gain prevention intervention in mid-age women: Two year results from the 40-something randomized control trial.	2019	https://dx.doi.org/10.3390/nu11051100

N.B. These documents automatically identified may not have been verified by the study sponsor.

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