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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611000064909
• Date of registration: 18/01/2011
• Prospective Registration: No
• Primary sponsor: Professor Lauren Williams, University of Canberra
• 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.
• Date of first enrolment: 25/05/2010
• Target sample size: 54
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12611000064909.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Lauren Williams

• Name: Dr Lauren Williams

Key inclusion & exclusion criteria

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
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).

Age minimum: 44 Years
Age maximum: 50 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Weight gain;Abdominal Obesity;
Weight gain
Abdominal Obesity

Diet and Nutrition - Obesity

Intervention(s)

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. Evalu

Primary Outcome(s)

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

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

Secondary Outcome(s)

6. Physical activity and dietary restraint using validated questionnaires[Baseline, 3 months and 12 months after commencing intervention to assess intervention effects, then at 24 months after intervention commencement to assess maintenance.]

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).[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.]

7. Perceived physical and mental health using the Short Form 36 (SF-36) questionnaire[Baseline and 12 months after commencing intervention to assess intervention effects, then at 24 months after intervention commencement to assess maintenance.]

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

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

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[Measured at baseline]

11. A process evaluation will be performed with a questionnaire to participants examining issues including study feasibility, participant satisfaction and suggestions for improvement.[measured 12 months after commencing intervention]

5. Food portion sizes will be assessed using items from the Cancer Council Victoria (CCV) Dietary Questionnaire for Epidemiological Studies (DQES v2)[Measured at baseline and 12 months after beginning the intervention]

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

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

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

Secondary ID(s)

Nil

Source(s) of Monetary Support

University of Newcastle

Secondary Sponsor(s)

Associate Professor Philip Morgan

Professor Clare Collins

Ethics review

Status: Approved
Approval date:
Contact:

University of Newcastle Human Research Ethics Committee