Supported by:

14.15 – 14.45

Testing the efficacy of the myspecialk online weight loss tool

Dr Margaret Ashwell Ashwell Associates

Speaking on behalf of Kellogg’s

Drink Well & Evidence Base

Testing the efficacy of the myspecialk online weight loss tool

Margaret Ashwell1, Elaine Howarth2, David Chesters2, Peter Allan2, Alexa Hoyland3, Jenny Walton4

1. Ashwell Associates, Ashwell Street, Ashwell, Hertfordshire, SG7 5PZ; United

Kingdom. Visiting Research Fellow ,Oxford Brookes University 2. Clinical Research Services. Intertek Chemicals & Pharmaceuticals

3.The University of Leeds Human Appetite Research Unit 4.The Kellogg Company

This study was funded by The Kellogg Company

Obes Facts 2014;7(6): DOI: 10.1159/000369193

3

The Evolution of Weight Management: From 1970s Pills to a Healthy Lifestyle in a digital age in 2010s

1970’s 1980’s 1990’s 2000’s 2010’s

Pills, Pills, Pills

No Pain, No Gain

Deprive, Work Out

Low Carb, Holistic Workout

Healthy Weight Management in

a digital age

The use of a customised weight loss website (which advocates breakfast eating)

can cause significant and long term

body mass and body fat loss

which is greater than that obtained from a standard weight loss website.

Hypothesis

“Does eating breakfast (cereal) as part of the “MySpecialK” weight loss website

cause significant and long term body mass and body fat loss?”

Our primary outcome was body mass

Research Question

1. Growing consistent evidence from cross- sectional studies in adults and children that those who eat RTEC for breakfast are slimmer than those who don’t. (But only limited biological mechanism for a causal relationship).

2. Various trials of internet weight loss programmes have been reported…. but it is difficult to draw a definitive conclusion on their potential impact

Background- two areas

Evidence is suggestive that regular consumption of breakfast cereals results in lower BMI in adults and children and adolescents

(de la Hunty et al, 2007 and 2013)

Evidence is suggestive that regular consumption of breakfast cereals results in lower BMI in children and

adolescents (de la Hunty et al, 2013)

Favours high RTEC

Favours low RTEC

Arem H, Irwin M (2011): A review of web-based weight loss interventions in adults.

Obes Rev ;12:e236-243

Review of nine randomized controlled trials on internet-delivered weight loss and maintenance programmes published in peer reviewed papers.

The trials showed results ranging from zero weight loss to an average loss of 7.6kg.

Conclusion: “It is difficult to draw a definitive conclusion on the potential impact of Internet-based weight loss: as study methods are highly variable between papers,

low adherence was recorded

and not all studies included a control group”

Meta-analysis of 23 studies comparing web users with non web user control groups.

Conclusion: the internet component in obesity treatment programs has a modest effect on weight control.

However, the effect was inconsistent, largely depending on the type of usage of the Internet or the period of its use.

Kodama S, Saito K, Tanaka S, Horikawa C, Fujiwara K, et al. (2011) Effect of Web-based lifestyle modification on weight control: a meta-analysis.

Int J Obes (Lond) 36: 675-685.

Mean difference in weight change (kg)

Systematic review of 14 weight loss studies and 4 weight maintenance studies

Concluded: interactive computer-based interventions are an effective intervention for weight loss and weight maintenance compared to no, or minimal, interventions (pamphlets, usual care).

But-compared to in-person interventions, interactive computer-based interventions result in smaller weight losses and lower levels of weight maintenance.

Wieland LS, Falzon L, Sciamanna CN, Trudeau KJ, Brodney S, et al. (2012) Interactive computer-based interventions for weight loss or weight maintenance

in overweight or obese people. Cochrane Database Syst Rev 8: CD007675.

Comparison of weight maintenance at 12m: computer vs. minimal intervention

Comparison of weight loss at 6m: computer vs. minimal intervention

Single centre, single blind, randomised parallel study.

Used the data on attrition rates within other studies (ave. 30%) to power this study (80% chance of detecting a standardised difference of 0.50 at a 2-sided significance level of 5%).

Test group followed a fully interactive website (B) with ‘prescribed’ breakfast cereals (RTEC). Control group followed website (A) giving standard advice on weight loss.

Study site visits at 0, 4, 12 and 24 weeks for measurements of height, weight, skinfolds, body fat, waist and hip circumference.

180 subjects were randomly allocated to two equal groups. Subjects were in good health, aged 19-50 years, with a BMI ranging from 25-40 kg/m2.

At baseline there was no difference in mean age or BMI of the two groups.

Our Methods

Why waist? New mortality study: “Waist-to-height ratio is more predictive of years of

life lost than body mass index” (Ashwell et al, 2014) supports the simple message:

"Keep your waist circumference to less than half your height”

ASHWELL, M., MAYHEW, L., RICHARDSON, J. & RICKAYZEN, B. ( 2014) Waist-to-height ratio is more predictive of years of life lost than body mass index. PLOS One, 9 e103483. Ashwell, M., P. Gunn and S. Gibson (2012). "Waist-to-height ratio is a better screening tool than waist circumference and BMI for adult cardiometabolic risk factors: systematic review and meta-analysis." Obes Rev 13(3): 275-86.

Ashwell M, Mayhew L, Richardson R, Rickayzen B (2014) Waist-to-height ratio is more predictive of years of life lost than body mass index. PLOS One (in press). BMI=BURY ME IMMEDIATELY!

Test website B

( MySpecialK.co.uk )

Control website A

( ‘partial’ attention control)

Personalised

•personal meal plan, always including breakfast, for each individual based on their lifestyle and needs.

Interactive •food diary, shopping function, weight tracker, emotional tracker, waist tracker and an exercise tracker • buddy system, the forum and BMI calculator. •smart phone application

RTEC • subjects had a continual supply of ready to eat cereal (RTEC) and snacks .

Standard dietetic advice on weight loss : •healthy weight loss, • top tips for weight loss, • food and exercise •portion control, •eating out •simple exercises •advantages of a food diary and how to keep a detailed record of all the food and drink consumed each day. •BMI calculator only at baseline .

Study Schematic

Participant flow shows that 90 started in each group and 62/64 completed at end 24wks

Included in ITT analysis: n=90 in both groups Included in Completers analysis: n=62 (website A) and n=64 ( website B)

Most dropouts during first 12 wks

ITT population P value* Completers population P value*

Control Website A

(n=90)

Test Website B

(n=90)

Control Website

A (n=62)

Test Website B

(n=64)

age(y) 38.2 (7.1) 37.7(7.4) 0.63 38.9 (6.9) 38.8(6.8) 0.88

height (m) 1.63(0.1) 1.63(0.1) 0.98 1.63(0.1) 1.63(0.1) 0.89

body mass (kg) 82.5(11.5) 83.5(11.1) 0.53 80.5 (11.6) 83.1(10.1) 0.18

BMI (kg/m2) 31.1(3.8) 31.5(4.0) 0.46 30.4(3.7) 31.4(3.9) 0.14

fat mass (kg) 37.0(8.8) 38.0(8.1) 0.44 35.5(8.8) 37.7(7.6) 0.14

waist circ.(cm) 100.2 (11.5) 100.4 (9.1) 0.87 98.9 (11.6) 100.8(8.9) 0.30

hip circ. (cm) 111.6 (7.5) 113.2 (9.1) 0.20 110.3(7.2) 112.5(8.2) 0.11

waist to hip

ratio

0.90 (0.08) 0.89 (0.06) 0.39 0.90(0.09) 0.90(0.05) 0.99

waist-to-height

ratio

0.61 (0.07) 0.62 (0.06) 0.80 0.61(0.07) 0.62(0.06) 0.28

Baseline characteristics of participants showed no significant differences

All values expressed as mean (SD) *p value calculated using two sample t test

the percentage change in body mass loss was significantly greater when following the test website B than the control website A

n=90 in each group; repeated measures ANOVA p=0.013

Results on Intention to Treat (ITT) basis after 24 wks

After 24 weeks % change from baseline

Website A Website B Website A Website B P valuea P valueb

body mass

(kg)

81.5(11.4) 81.6(11.7) -1.1(3.4) -2.4(4.0) 0.015 0.013

BMI (kg/m2) 30.7(3.9) 30.8(4.3) -1.1(3.4) -2.4(4.0) 0.015 0.013

fat mass (kg) 35.6(8.8) 35.8(8.9) -3.6 (7.2) -6.1(8.8) 0.051 0.130

waist circ.(cm) 95.08 (10.30) 94.85 (9.73) -4.83 (5.55) -5.51 (4.88) 0.153 0.616

hip circ. (cm) 111.06 (7.16) 111.15 (9.10) -0.38 (2.66) -1.69 (4.13) 0.021 0.005

waist to hip

ratio

0.86 (0.07) 0.86 (0.08)

waist-to-height

ratio WHtR)

0.58 (0.06) 0.58 (0.07)

ITT analysis at 24wks:

Test website B group lost significantly more body mass

than Control website A group

All values expressed as mean (SD)

Comparing 24wk values with baseline website A vs. B:

a p value calculated using Wilcoxon two-sample test (compare

website mean % changes from baseline at week 24)

Comparing values at all timepoints with baseline website A vs.

B:

b p value calculated using repeated measures ANOVA

(compare website mean % changes from baseline across all

time points (weeks 0, 4, 12 and 24).

the percentage change in body mass loss was significantly greater for website B than website A

Numbers of completers

Control website A=62/90

Test website B=64/90

repeated measures ANOVA p=0.023

Results for completers at 24wks

After 24 wks % change from baseline

Website A Website B Website A Website B P value a P value b

body mass (kg) 79.1(11.1) 80.6(10.7) -1.5(3.9) -3.1(4.5) 0.037 0.0234

BMI (kg/m2) 29.9(3.7) 30.4(4.3) -1.5(3.9) -3.1(4.5) 0.037 0.0234

fat mass (kg) 33.5(8.2) 34.8(8.5) -5.3 (7.9) -8.0(9.8) 0.095 0.0555

waist circ.(cm) 92.21(8.9) 93.34(9.4) -6.38(5.9) -7.41(4.2) 0.038 0.5055

hip circ. (cm) 109.71(6.5) 109.71(8.0) -0.42(3.0) -2.36(4.7) 0.012 0.0013

waist to hip ratio 0.84(0.06) 0.85(0.09)

waist-to-height

ratio (WHtR)

0.57(0.05) 0.57(0.07)

Completers at 24wks: Test website B group lost significantly

more body mass than Control website A group

All values expressed as mean (SD)

Comparing 24wk values with baseline website A vs. B: :

a p value calculated using Wilcoxon two-sample test (compare website mean %

changes from baseline at week 24)

Comparing values at all timepoints with baseline website A vs. B: :

b p value calculated using repeated measures ANOVA (compare website mean % changes from baseline across all time points (weeks 0, 4, 12 and 24).

Percentage difference in MEAN BODY MASS loss

from baseline over time in completers - significantly different between groups

-3.5

-2.5

-1.5

-0.5

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Pe

rce

nta

ge lo

ss o

f B

od

y M

ass

Time (wks)

A BWebsite

MeaControl Website A :Mean body mass loss= 1.3kg

Test Website B: Mean body mass loss= 2.5kg

Comparing across groups P=0.023

Percentage difference in MEAN FAT MASS loss

from baseline over time in completers shows mass loss not just due to water loss

-8

-6

-4

-2

0

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Per

cen

tage

Lo

ss o

f Fa

t M

ass

Time A BWebsite

Test website B: Mean body fat loss= 2.9kg

Control website A: Mean body fat loss= 2.0kg

Comparing across groups P= 0.056

Difference in fat mass loss was borderline significance between groups- but still shows body mass loss was not just due to water loss

Discussion of UK results

Strengths of our study: Fully randomised controlled trial Good retention rates so study sufficiently powered Primary and secondary outcomes ITT analysis

Limitations: Subjects in test group were not blinded to intervention We cannot tell if the improved results with website B were due to:

• more interactive/motivating website? • inclusion of RTEC in meal plans? • Supply of RTEC?

Comparison between methods used for UK and French studies

(different diets, different cultures)

UK France

Number of subjects 180 overweight women (mean BMI 31, mean age 38y)

70 overweight women (mean BMI 28, mean age 33y )

Study design Single centre, Single blind , RCT over 6m Single arm study over 3m, plus 3m wt maintenance period

Time period Summer 2011 March 2012 to October 2012

Websites for wt loss Two websites for two groups in trial: •Website A that gave standard advice on weight loss with less interaction •Website B (“My SpecialK”)- an interactive website that included prescribed breakfast cereals ( including supply)

Specific cereal-based website adapted for French consumers

Foods provided Supplies of SpecialK as prescribed by website during trial

None prescribed

Measurements BMI, fat mass, waist circumference, hip circumference

BMI, fat mass, waist circumference, hip circumference

Comparison of results of UK and French studies

(different diets, different cultures)

UK France

% completers at 6m 70% 70%

% change in body mass loss when following Test website compared with Control website (ITT analysis)

n=90 in both groups; Repeated measures ANOVA showed a significant difference between groups across all time points up to 6 months (p=0.013).

n=70 t-test showed significant difference between baseline and 3 months, and between baseline and 6 months (P<0.0001)

Comparison of % change in body mass loss when following Test website compared with Control website (Completers analysis)

n=62 controls vs. n=64 test group Repeated measures ANOVA showed a significant difference across all time points up to 6 months (p=0.023).

n=49 One sided t-test showed a significant difference between baseline and 3 months, and baseline and 6 months(P<0.0001)

Fat mass loss Loss (borderline significance p=0.056) of fat mass to show body mass loss was not due to water loss.

Significant loss in fat mass without loss of muscle mass (p<0.001)

ITT intention to treat; ANOVA, analysis of variance;

The advice and motivation offered by an interactive website, including consumption of breakfast cereals, results in significantly greater loss of body mass compared to the use of a standard website.

This loss of body mass is not just due to water loss since fat mass also decreased

We cannot tell whether the improved results with the “MySpecialK.co.uk” website were due to: more interactive/motivating website?

inclusion of RTEC in meal plans?

Supply of RTEC?

Conclusions from both studies

Testing the efficacy of the myspecialk online weight loss tool

Margaret Ashwell1, Elaine Howarth2, David Chesters2, Peter Allan2, Alexa Hoyland3, Jenny Walton4

1. Ashwell Associates, Ashwell Street, Ashwell, Hertfordshire, SG7 5PZ; United

Kingdom. Visiting Research Fellow ,Oxford Brookes University 2. Clinical Research Services. Intertek Chemicals & Pharmaceuticals

3.The University of Leeds Human Appetite Research Unit 4.The Kellogg Company

This study was funded by The Kellogg Company

Obes Facts 2014;7(6): DOI: 10.1159/000369193