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Nutritive and Non-Nutritive Sweeteners

NNNS: Effect of Sucralose on Appetite and Food Intake (2011)

Citation:

Rodearmel SJ, Wyatt HR, Stroebele N, Smith SM, Ogden LG, Hill JO. Small changes in dietary sugar and physical activity as an approach to preventing excessive weight gain: The American on the Move family study. Pediatrics. 2007 Oct; 120(4): e869-e879. 

 

PubMed ID: 17908743
 
Study Design:
Randomized Controlled Trial
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Positive POSITIVE: See Quality Criteria Checklist below.
Research Purpose:

 

To evaluate further whether the small-changes strategy recommended by America on the Move (AOM) could be effective in preventing excessive weight gain in families with overweight children.

Inclusion Criteria:
  • Families had to have at least one child (seven to 14 years old) who was overweight or at risk for overweight (BMI in the 85th percentile or higher, based on Centers for Disease Control and Prevention criteria)
  • Families had to have two or more individuals living in the same household and having some emotional bond
  • At least one parent or guardian had to agree to participate in the study.

 

 

Exclusion Criteria:
  • Parent or child had health condition that prevented engagement in physical activity
  • Pregnancy or lactation.
Description of Study Protocol:

Recruitment

Print materials sent via mail or e-mail to schools, pediatrician offices, health organizations and community organizations; a phone number was provided for interested parents or guardians to obtain more information. 828 families were screened by telephone; 298 families qualified for the study.

Design

Randomized controlled trial (not blinded).

Intervention 

Families were randomly assigned to one of two groups:

  • AOM group:
    • Asked to increase daily steps by 2,000 per day above baseline as measured by pedometers
    • Were asked to reduce daily caloric intake by 100kcals per day by replacing dietary sugar with a non-caloric sweetener (Splenda no-calorie sweetener or sucralose-containing beverages were emphasized)
      • Families completed a survey on usual sweetened food and beverage consumption; family-specific suggestions for replacing 100kcals per day of dietary sugars with sucralose were provided to each family
      • Families received education in label reading with an emphasis on sugar and sugar-substitute terminology
      • Families were provided with information on a variety of sucralose-sweetened foods and beverages, as well as information on baking and cooking and preparing foods using sucralose
      • Families were educated on the importance of eating breakfast, cooking meals at home, and the Five-a-Day campaign to increase fruit and vegetable consumption
      • Families were provided with sucralose sweetener packets and sucralose-sweetened bulk granular for cooking and baking
      • Sample recipes and a small allowance for purchasing sucralose-sweetened beverages were provided to participants
  • Self-monitor only group:
    • Were provided with pedometers and asked to record daily steps
    • Were asked to complete a survey on sweetened food and beverage consumption at the beginning and end of study
    • Were not asked to make specific changes; were asked only to record usual lifestyle information. 

Statistical Analysis

  • Primary outcome was BMI-for-age analyzed on the z-score scale
  • Calculated by using the Box-Cox transformation (L), median (M) and generalized coefficient of variation (S) parameters corresponding to the Centers for Disease Control and Prevention BMI-for-age growth charts
  • Data analyzed by SAS (SAS Institute Inc., Cary, California)
  • Two-sided significance tests with a significance level of 0.05 were used
  • Differences between group means were compared with independent sample T-tests
  • Changes within groups were compared using paired T-tests
  • A repeated-measures mixed model was used to provide intent-to-treat analysis
  • Percentages of children who maintained or reduced BMI at six months were compared between groups using Pearson X2 analysis
  • Children were the primary target of the intervention, and parents or guardians were the secondary target.
Data Collection Summary:

Timing of Measurements

The study lasted 6.5 consecutive months, including a two-week baseline period and a 24-week intervention period.

  • Families from both groups met with study staff on six occasions, as follows:
    • At study enrollment (meeting one)
    • After baseline period at two weeks (meeting two)
    • At the end of intervention weeks six, 12, 18 and 24
  • Outcome measures and participant data were collected at these points.

Dependent Variables

  • Change in BMI-for-age z scores for children
  • Change in BMI for parents.

Independent Variables

  • Physical activity was measured for all participants in both groups by using steps recorded by pedometer daily throughout weeks one to 18 and during week 24
  • Consumption of foods sweetened with sugar and non-caloric sweeteners was assessed for both groups by completion of a sweets survey at baseline and at study completion.

Control Variables

Self-monitor-only control group.

 

Description of Actual Data Sample:
  • Initial N: 298 families (149 AOM group, 149 SM group after initial recruitment; 100 AOM, 93 self-monitoring began the study)
  • Attrition (final N): Attrition among AOM children and parents and SM children and parents ranged from 6% to 25%.

Age

  • AOM children: 11.11±2.08 years
  • SM children: 11.28±2.29 years. 

Ethnicity

  • AOM children: 52.59% white, 13.79% black, 13.79% Hispanic, 19.83% other
  • SM children: 50.98% white, 18.63% black, 12.75% Hispanic, 15.69% other.

Anthropometrics

  • AOM children: Body weight 58.3±18.6kg; BMI 25.40±4.22; BMI percentile 95.39; body fat percentage 29.07±6.64
  • SM children: Body weight 57.7±19.4kg; BMI 24.75±5.04; BMI percentile 96.05; body fat percentage 27.49±6.15.

Location

Denver, Colorado.

Summary of Results:

Key Findings

  • For children:
    • Children in both groups achieved significant decreases in BMI-for-age z score
    • Significantly more children in the AOM group reduced or maintained BMI-for-age than SM children (P<0.05)
    • Fewer AOM children showed an increase in BMI when compared to SM children (P<0.05)
    • AOM children reported significantly more steps per day throughout the study than SM children (P<0.05)
    • Compared to SM children, AOM children ate fewer sugar-sweetened desserts (P<0.01), fewer non-dessert sugar-sweetened foods (P<0.001), and less table sugar (P<0.001)
    • Children in both groups reported achieving the goal of eliminating 100kcals per day from their diets on 78% of study days. The most frequent method of cutting calories was to replace sugar with sucralose
  • For parents:
    • At baseline, SM parents' steps per day were significantly higher than AOL parents (8,737±3,660 steps per day vs. 7,518±2,777 steps per day; P<0.05); however, AOL parents quickly overtook SM parents and achieved significantly more steps per day throughout the study (P<0.05)
    • There were no significant differences between groups in BMI change-over-time, waist circumference, or percentage body fat
    • Compared to SM parents, AOM parents ate fewer sugar-sweetened desserts (P<0.005), fewer non-dessert sugar-sweetened foods (P<0.012) and less table sugar (P<0.001)
    • AOM parents reported achieving the goal of eliminating 100kcals per day from their diets on 77% of study days. The most frequent method of cutting calories was to replace sugar with sucralose.

Study Data

Variables

AOM Group

Measures and Confidence Intervals

SM Group

Measures and Confidence Intervals

Statistical Significance of Group Difference

Children's percentage of body fat

- 0.262±2.633, NS -0.072±2.363, NS P=0.611, NS

Children's change in waist circumference

 -0.682±4.385, NS

-0.219±4.127, NS

P=0.462, NS

Children's change in BMI-for-age z-score

- 0.066±0.166, P<0.05 within group

-0.039±0.169, P<0.05 within group

P=0.282, NS

Parents' change in body weight during study -0.38±2.6kg, NS -0.01±2.89kg, NS NS

 

Other Findings

Neither parents or children in the AOM group achieved step goals although increases were significant; increases achieved were approximately half the desired goals.

 

Author Conclusion:
  • The "small changes" approach implemented in this study was effective in limiting weight gain in children at risk of overweight or overweight
  • Pedometers and the non-nutritive sweetener sucralose were helpful in achieving lifestyle changes
  • The "small changes" strategy may be helpful in limiting excessive weight gain in all family members.
Funding Source:
Government: NIH
Industry:
McNeil Nutritionals
Pharmaceutical/Dietary Supplement Company:
Reviewer Comments:
  • There was no non-intervention control group; differences between the AOL and SM groups may not be generizable since self-monitoring may be considered an intervention
  • Provision of free sucralose products to AOL families may have influenced use of these products.
Quality Criteria Checklist: Primary Research
Relevance Questions
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  1. Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  2. Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  3. Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
  1. Was the research question clearly stated? Yes
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? Yes
  1.3. Were the target population and setting specified? Yes
  2. Was the selection of study subjects/patients free from bias? Yes
2. Was the selection of study subjects/patients free from bias? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.1. Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.3. Were health, demographics, and other characteristics of subjects described? No
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
  3. Were study groups comparable? Yes
3. Were study groups comparable? Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.1. Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? Yes
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) No
  3.3. Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) No
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.4. If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.5. If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
  3.6. If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? N/A
  4. Was method of handling withdrawals described? Yes
4. Was method of handling withdrawals described? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.1. Were follow-up methods described and the same for all groups? Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.2. Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.4. Were reasons for withdrawals similar across groups? Yes
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
  4.5. If diagnostic test, was decision to perform reference test not dependent on results of test under study? N/A
  5. Was blinding used to prevent introduction of bias? No
5. Was blinding used to prevent introduction of bias? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.2. Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) No
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.3. In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.4. In case control study, was case definition explicit and case ascertainment not influenced by exposure status? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
  5.5. In diagnostic study, were test results blinded to patient history and other test results? N/A
  6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
6. Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? Yes
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.2. In observational study, were interventions, study settings, and clinicians/provider described? N/A
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? Yes
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? No
  6.6. Were extra or unplanned treatments described? No
  6.6. Were extra or unplanned treatments described? No
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.7. Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? Yes
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
  6.8. In diagnostic study, were details of test administration and replication sufficient? N/A
  7. Were outcomes clearly defined and the measurements valid and reliable? Yes
7. Were outcomes clearly defined and the measurements valid and reliable? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.1. Were primary and secondary endpoints described and relevant to the question? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.2. Were nutrition measures appropriate to question and outcomes of concern? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.5. Was the measurement of effect at an appropriate level of precision? Yes
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.6. Were other factors accounted for (measured) that could affect outcomes? No
  7.7. Were the measurements conducted consistently across groups? Yes
  7.7. Were the measurements conducted consistently across groups? Yes
  8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.1. Were statistical analyses adequately described and the results reported appropriately? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.2. Were correct statistical tests used and assumptions of test not violated? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.3. Were statistics reported with levels of significance and/or confidence intervals? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.4. Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.6. Was clinical significance as well as statistical significance reported? Yes
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
  8.7. If negative findings, was a power calculation reported to address type 2 error? No
  9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
  10. Is bias due to study's funding or sponsorship unlikely? ???
10. Is bias due to study's funding or sponsorship unlikely? ???
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? ???
  10.2. Was the study free from apparent conflict of interest? ???