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Trial registered on ANZCTR

Registration number

ACTRN12615000198527

Ethics application status

Approved

Date submitted

17/02/2015

Date registered

2/03/2015

Date last updated

24/03/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomized-controlled-trial of passive heating or cooling to improve sleep and facilitate weight loss in overweight/obese individuals.

Scientific title

A randomized-controlled-trial of passive heating or cooling to improve sleep and facilitate weight loss in overweight/obese individuals.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1167-2153

Trial acronym

Linked study record

Health condition

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

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In this randomized controlled trial (RCT), we will evaluate the effects of instructing overweight/ obese individuals to take a hot or cold bath/shower (whichever is preferred) about 90-minutes prior to the time they wish to go to sleep, to determine whether this is effective in: (a) improving their sleep quality and increasing sleep times, and (b) as a consequence of going to bed earlier and sleeping a longer time, eat substantially less at night and therefore reduce their weight over time, relative to the control group participants. Based on the empirical studies where participants took a hot bath/shower as a modality of passive body heating (Allehe et al. 2013; Cynthia, 1996), the water temperature was 41-42 degrees Celsius. In our study, we will advise the participants who are taking a hot bath/shower to make it as hot as they feel comfortable with, which should be around this water temperature. However, it is important not to give too detailed instructions that are disparate in extent to the participants who instead seek to take a cold bath/show. The participants will also be asked to complete the study questionnaire prior to being randomized to a study group, then they will participate in their group’s activities for 3-months (i.e. reviewing and enacting the sleep hygiene information), and then completing the follow-up questionnaire. Finally, the intervention condition will involve the participants either taking a hot/cold bath or shower every night for 3-months, whichever is preferred), and completing the baseline and follow-up questionnaires.

Several strategies will be used to ensure that the study participants do adhere to the instructions they received. First, we will instruct them to complete the diary as accurately as they can and remind them that we are not testing them, but rather the effectiveness of a potential new weight loss program. Third, we will telephone all participants (including the control group participants) after 1-week and 1-month to check on their engagement in their group activities, and to remind them to complete the questionnaire at the end of the study.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

The first control condition is a Normal bedtime protocol group . Participants who are randomised to this group will simply be asked to complete the same questionnaires that are being completed by the other two study groups. The second control condition involves the participants reading an information page about typical sleep hygiene training (i.e. ways in which they might improve their sleep, e.g. reduce caffeine intake after lunch, don’t use too much bedding, etc.). This sheet is simply an instruction sheet designed for the study and attached with a daily diary sent to the participants via email after they will be randomised to the allocated group. Reading the instructions and filling up the diary wont take 10 minutes. They will also be asked to complete the study questionnaire (detailed below) prior to being randomized to a study group, then they will participate in their group’s activities for 3-months (i.e. reviewing and enacting the sleep hygiene information), and then completing the follow-up questionnaire. Finally, the intervention condition will involve the participants either taking a hot/cold bath or shower every night for 3-months, whichever is preferred), and completing the baseline and follow-up questionnaires

Control group

Active

Outcomes

Primary outcome [1]

Weight loss.
This outcome will be assessed using digital weighing scale.

Timepoint [1]

at 3 months after randomisation

Primary outcome [2]

Quality of sleep assessed using the Pittsburgh Sleep Quality Index (PSQI)

Timepoint [2]

at 3 months after randomization

Secondary outcome [1]

Physical activity levels assessed using physical activity diary and the Global Physical Activity Questionnaire v2.0

Timepoint [1]

at 3 months period after randomization

Secondary outcome [2]

Night eating assessed using the Night Eating Questionnaire (NEQ).

Timepoint [2]

At 3 months after Randomization

Secondary outcome [3]

Binge-eating assessed using the Binge-Eating Scale (BES).

Timepoint [3]

at 3 months after randomization

Eligibility

Key inclusion criteria

Criteria for Inclusion Study inclusion criteria are as follows: (i) participants are required to be overweight or obese; (ii) over 18 years and less than 66 years of age, and (iii) able to bathe themselves or have a regular carer who can arrange this for them.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Criteria for Exclusion: The study exclusion criteria are detailed as follows: including people who are: (i) under 18 years of age or older than 65-years; (ii) underweight or normal weight; or (iii) pregnant.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

Participants will be randomly assigned to one of the three groups using a random-generator computer program.

Allocation is not concealed

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

Participants will be randomly assigned to one of the three groups using a random-generator computer program.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

In regards to the justification of the sample size, and based on the small relevant studies of passive body heating on body temperature and sleep, the largest sample had 23 participants in each group, and the smallest subsample had 5 participants. Nonetheless, an a priori power analysis is provided separately for the planned between-groups analyses. In the between-groups analyses (i.e.1 experimental vs 2 control groups), this calculation was based on an estimated effect size of .25 (small to moderate), with alpha set at .05, power set at .9, and using up to 6 predictors, critical F(6,70)=2.23. This calculation indicated that only N=77 participants were required, i.e. about 25 participants in each of the three groups. The between-groups analyses will evaluate whether the intervention condition can facilitate weight loss over 3-months, relative to the study control groups.

Recruitment

Recruitment status

Withdrawn

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

1/05/2016

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment outside Australia

Country [1]

Canada

State/province [1]

vancouver

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Australian National University

Address [1]

Canberra ACT 2601

PO Box 0200

Country [1]

Australia

Primary sponsor type

University

Name

Australian National University

Address

The Australian National University

Canberra ACT 2601

PO Box 0200

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human ethics - Research Services - ANU

Ethics committee address [1]

Human Ethics Manager
Research Integrity & Compliance,
Research Services,
Ground Floor, Chancelry 10B
Ellery Crescent,
The Australian National University
ACTON ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2016

Approval date [1]

29/04/2016

Ethics approval number [1]

2015/013

Summary

Brief summary

In this study, a number of specific between-groups hypotheses will be tested in the randomized controlled trial as detailed below:

H1: Participants in the experimental group will experience improved sleep quality, relative to the study controls, between baseline and follow-up at 3-months;

H2: Participants in the experimental group will lose a greater amount of weight, relative to the study controls, between baseline and follow-up at 3-months;

Further, a number of within-subjects hypotheses will be tested:

H3: 	The relationship between study group (i.e. hot/cold bath vs. study controls) and weight loss between baseline and 3-months follow-up will be mediated by the drop in mean core body temperature and improved sleep quality; and, 

H4:	The relationship between study group and weight loss between baseline and 3-months will be mediated by a reduction in binge- and/or night-time eating, which is due to the longer time spent asleep and less time sitting up at night. That is, participants who do not engage in eating late at night are expected to lose more weight than those who do eat late at night.

In the analyses pertaining to the hypotheses, we will control for all variables that are correlated with the outcome variables (i.e. sleep quality, and BMI), including symptoms of anxiety/ depression and a lack of exercise/physical activity, as well as certain conditions (e.g. hypothyroidism) or treatments (e.g. antidepressants), if appropriate.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Shireen Eid

Address

The Australian National University

Canberra ACT 2601

PO Box 0200

Country

Australia

Phone

+61402011004

Fax

shireen.eid@anu.edu.au

Contact person for public queries

Name

Rhonda Brown

Address

The Australian National University
CANBERRA ACT 2601
PO Box 0200

Country

Australia

Phone

+61 2 6125 0635

Fax

rhonda.brown@anu.edu.au

Contact person for scientific queries

Name

Rhonda Brown

Address

The Australian National University
CANBERRA ACT 2601
PO Box 0200

Country

Australia

Phone

+61 2 6125 0635

Fax

rhonda.brown@anu.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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