A Telephone Based Diabetes Prevention Program and Social Support for Weight Loss The Call 2 Health Study FULLER

A Telephone-Based Diabetes Prevention Program and Social Support for Weight Loss:

the Call-2-Health Study Presenter: Sharon FullerCo-authors: Evette Ludman, PhD; Amy Mohelnitzky MEd;

Gabrielle Gundersen; Rob Wellman, MS; Rob Reid, MD, PhD; Katherine Newton, PhD

HMORN 2012 ConferenceMay 2, 2012Funded by NIDDK R34 DK076555

Call-2-Health

Diabetes Prevention Program (DPP) translation Goal to design an intervention that:

Is effective in diverse populations and settings Is affordable Has reach

2-year pilot study (R34 - NIDDK) Randomized controlled trial Effect on weight loss and exercise of telephonic behavioral

intervention modeled on the DPP vs. usual care

Main Study Aims1. Evaluate feasibility / acceptability

2. Conduct a preliminary evaluation of the intervention’s effectiveness

3. Inform the design and implementation of a full-scale effectiveness trial

Sub-Analysis Aims

assessed the impact of Call-2-Health on participants’ report of support for dietary changes from family and friends

examined the correlation of social support for dietary changes with weight loss success

On the hypothesis that social support may be critical to long-term maintenance of behavioral changes, we:

Inclusion Criteria From automated records

Male or female Age 45-74 BMI ≥ 25 kg/m2 Fasting plasma glucose 105-125 mg/dl or A1C 5.7-6.4 Receives primary care at Group Health’s Central, Rainier,

or Poulsbo Clinic

Followed up with phone screening and laboratory tests to confirm eligibility and willingness to participate

Exclusion Criteria Medical History

Type 1 or 2 diabetes FPG <105 or >125 mg/dl at screening blood draw HbA1C <5.7 or >6.4 at screening blood draw Exercise ≥ 30 minutes/day, at least five days a week Current participation in another structured weight loss

program or intervention study Severe concurrent disease Unable to walk ≥ 10 minutes

Logistics Unavailable for the 24-week study period Unable to read or speak English

InterventionParticipants randomly assigned to usual care (UC) and

intervention groups (IG) for the 24-week study

Usual Care (n=23) Clinic visits at baseline, 12 and 24 weeks, including

physical measures, blood tests and collection of questionnaires

Three UC participants failed to complete the study

Intervention Group (n=24) Usual Care plus 12 weekly intervention calls and 4

maintenance calls over the following 12 weeks IG participants completed 95% of intervention calls

Sallis Social Support Scale – Eating Habits Separate measures of encouraging and

discouraging behaviors by family and friends

Five questions per measure

Answers “none” (1) to “very often” (5) based on behaviors in the last three months

Scored by totaling points (possible range 5-25 points)

Social Support for Eating Habits - ItemsEncouragement Encouraged me not to eat

“unhealthy food” (cake, potato chips) when I am tempted to do so

Discussed my eating habit changes with me (asked me how I am doing with my eating changes)

Reminded me not to eat high fat, high calorie foods

Complimented me on changing my eating habits (“Keep it up”, “We are proud of you”)

Commented if I went back to my old eating habits

Discouragement Ate high fat or high calorie foods

in front of me Refused to eat the same foods I

eat Brought foods I am trying not to

eat Got angry when I encouraged

them to eat low calorie, low fat foods

Offered me food I am trying not to eat

Results

Recruitment Mailings (n=438)(Male = 228, Female = 210)

Ineligible (n=200)Refusal (n=191)

Usual Care (n=23)

Intervention (n=24)

Lost to follow-up (n=2)Withdrew (n=1)

Randomized (n=47)(stratified by clinic and sex)

Participant Characteristics at Baseline Usual Care (n=23) Intervention (n=24)

Age, mean (SD) 56.9 (8.2) 59.7 (8.3)

Female, % 52% 50.0%

Married or cohabiting, % 77.3% 70.8%

Hispanic, % 0% 8.3%

Race, %

White 72.7% 83.3%

Black 22.7% 12.5%

Asian 4.6% 0.0%

Other 0.0% 4.2%

Weight, mean (SD) (Kg) 90.5 (21.9) 101.9 (21.8)

BMI, mean (SD) (Kg/M2) 31.4 (5.3) 35.0 (7.2)

FPG, mean (SD) (mg/dL) 105.3 (7.7) 106.8 (8.9)

HbA1C, mean (SD) (%) 5.8 (0.3) 5.8 (0.3)

Participant Characteristics at BaselineSallis Eating Habits Social Support Scores, mean (SD) Usual Care Intervention

Encouragement

Family 12.1 (6.5) 12.1 (5.8)

Friends 8.6 (4.8) 6.7 (2.3)

Discouragement

Family 11.0 (4.8) 9.1 (4.2)

Friends 9.6 (4.0) 10.7 (4.7)

Outcomes – Weight Loss

24 Weeks

Usual Caren=21

Interventionn=23

Differencep

Mean (95% CI) Mean (95% CI) Mean (95% CI)

Weight (Kg) 94.9 (92.8, 96.9)

88.0 (85.3, 90.6)

-6.9 (-10.2, 3.5)

<.0001

BMI (Kg/M2) 32.7 (32.0, 33.4)

30.3 (29.4, 31.2)

-2.4 (-3.5, -1.3)

<.0001

Achieved 7% Weight Loss (%)

15.6 (-12.8, 43.9)

65.9 (28.4, 103.3)

50.3 (25.7, 74.8)

<.0001

adjusted for baseline weight

Outcomes – Eating Habits Social Support24 Weeks

Usual Care Interventionp

Mean (95% CI) Mean (95% CI)

Encouragement

Family 12.7 (10.8, 14.6)

16.5 (14.4, 18.6)

.013

Friends 7.8 (6.5 ,9.2)

10.6 (9.2,12.0)

.004

Discouragement

Family 9.6 (7.8,11.3)

10.0 (9.1,11.0)

.672

Friends 9.4 (7.7,11.0)

9.9 (8.8,11.0)

.575

adjusted for baseline weight, age and baseline score

Correlation between weight loss and change in dietary encouragement - family

UC: r = -0.69 (CI= -0.88, -0.28)

IG: r = -0.56 (CI= -0.80, -0.12)

UC

IG

24 Weeks

chan

ge in

wei

ght

(Kg)

change in encouragement score

Correlation between weight loss and change in dietary encouragement - friends

UC: r = -0.34 (CI = -0.68, 0.13)

IG: r = -0.40 (CI = -0.71, 0.04)

UC

IG

chan

ge in

wei

ght

(Kg)

change in encouragement score

24 Weeks

Correlation between weight loss and change in dietary discouragement - family

UC: r = -0.28 (CI= -0.68, 0.25)

IG: r = -0.25 (CI= -0.63, 0.24)

UC

IG

change in discouragement score

chan

ge in

wei

ght

(Kg)

24 Weeks

Correlation between weight loss and change in dietary discouragement - friends

UC: r = -0.41 (CI= -0.72, 0.05)

IG: r = -0.56 (CI= -0.79, -0.16)

UC

IG

change in discouragement score

chan

ge in

wei

ght

(Kg)

24 Weeks

Discussion correlation <> causality

logical to hypothesize that increased encouragement facilitates weight loss

also logical to hypothesize that weight loss triggers discouragement from friends

haven’t proven either one wide variability in score changes; sometimes

changes larger in UC than IG possible changes in perception or in participant

rather than actual changes in support – particularly in IG

small N means less power to detect differences

Conclusion The intervention did not specifically target

increasing social support, but made a bigger difference in support scores than expected.

Consistent with the literature, we found very high correlation between weight loss and increase in perceived social support for dietary changes, though the question of causality remains open.

Future Research DirectionsUsing existing data: compare increase in pedometer steps with changes in

social support for exercise explore results of other weight-loss specific measures

Additional research: larger N longer follow-up – once out of intensive weight loss

phase and into maintenance phase

Study Team

Katherine Newton, PhD Principal InvestigatorEvette Ludman, PhD Co-InvestigatorRob Reid, MD, PhD Co-Investigator David McCulloch, MD Co-InvestigatorGabrielle Gundersen Project Manager Amy Mohelnitzky, MEd InterventionistRob Wellman, MS BiostatisticianSharon Fuller ProgrammerJulie Reardon Research SpecialistAlison Thigpen MPH StudentMyrte Dikmans Master’s Student

Supplementary Slides

Correlation between encouragement and discouragement - friends

UC: r = -0.01 (CI= -0.44, 0.42)

IG: r = 0.34 (CI= -0.13, 0.67)

Change in discouragement score

UC

IG

chan

ge in

enc

oura

gem

ent

scor

e

change in discouragement score

24 Weeks

Participant Characteristics at BaselineSallis Eating Habits Social Support Scores, mean (SD) Usual Care Intervention

Encouragement

Family 12.1 (6.5) 12.1 (5.8)

Friends 8.6 (4.8) 6.7 (2.3)

Discouragement

Family 11.0 (4.8) 9.1 (4.2)

Friends 9.6 (4.0) 10.7 (4.7)

Participant Characteristics at BaselineSallis Social Support Scores, mean (95% CI) Usual Care Intervention p

Family n=18 n=19

Dietary Encouragement 12.11 (8.87,15.36) 12.05 (9.25,14.85) .98

Dietary Discouragement 11.00 (8.64,13.36) 9.05 (7.03, 11.08) .19

Exercise Participation 22.89 (17.85,27.93) 24.37 (19.10, 29.63) .67

Friends n=22 n=22

Dietary Encouragement 8.55 (6.43,10.66) 6.73 (5.70,7.75) .12

Dietary Discouragement 9.59 (7.80, 11.38)(n=23)

10.70 (8.66, 12.73) .40

Exercise Participation 18.86 (14.83,22.90)(n=24)

17.58 (13.96,21.21) .63

Change in Dietary Support