GDM: Physical Activity (2008)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
The evaluation of an intervention aimed at improving dietary intake during pregnancy, optimizing gestational weight gain, glycemic levels and birth weight, and avoiding unnecessary postpartum weight retention.
Inclusion Criteria:
All Cree women receiving prenatal services prior to 26 weeks' gestation in the communities of Chisasibi, Wemindji, Waswanipi and Mistissini between July 1995 and January 1997 were eligible.
Exclusion Criteria:
Women with pregestational diabetes.
Description of Study Protocol:

Recruitment Women recruited between July 1995 and March 1996 served as controls, whereas women identified between April 1996 and January 1997 made up the intervention group.  All participants gave signed consent.

Design Prospective Cohort 

Blinding used (if applicable) Not described

Intervention (if applicable)  The intervention was based on the social learning theory.  The table below outlines strategies and activities used in the intervention.

Dietary advice was related to improving the intake of dairy products and fruit and vegetables, while decreasing the intake of high-energy foods with little nutritional value such as soft drinks, fruit drinks and french fries and staying within guidelines for weight gain during pregnancy.

People Strategies Activities
Nutritionists Modeling Local radio broadcasts about healthy eating in pregnancy
Cree Health Workers Skill Training Pamphlets about nutritional choices and encouraging breastfeeding
  Contracting Supermarket tours and cooking demonstrations
  Self-monitoring Exercise/walking groups
    Individual Counseling

A baseline questionnaire provided demographic information, a brief prenatal history and information about smoking.  Dietary data were obtained by 24 hour recall at one time point between 24 and 30 weeks gestation and at 6 weeks post-partum.  Physical activity was measured at the time of the 24 hour diet recalls by a questionnaire related to usualy daily activities in both the village and the bush.

Infant birth weight and type of delivery were obtained from the medical charts.  The ratio of the measured birth weight to median birthweights specific to gestational age was used to compare birthweight among the Cree with non-Aboriginal standard.

Statistical Analysis  Participants were compared with nonparticipants living in their communities at the same time.  All participants were included in the intention-to-treat approach to the analysis.  Mean nutrient intakes, birth weight, birthweight ratio, gestational age, ratio of weight gain, glycemic level on the glucose screen and postpartum weight retention were compared for the treatment groups by independent t-tests, after adjusting for normality where warranted.  Log transformation was used to normalize pregravid weight, BMI and postpartum weight.  The sample size was sufficient for 80% power, using a 2-sided t-test to detect differences in birth weight of 215 g, energy intake of 1396 ks (12.6%), plasma glucose level of .74 (10%) mmol/L, rate of weight gain of .1 kg per week and postpartum weight retention of 1.9 kg.  It was not possible to have a sufficiently large sample size to detect differences in GDM rates.

Data Collection Summary:

Timing of Measurements  Physical activity and dietary information was collected between 24 and 30 weeks gestation and at 6 weeks postpartum.  A 50 g oral glucose screen test was performed between 24 and 30 weeks gestation, followed by a 100 g OGTT if the screen value was greater than 7.8 mmol/L. 

The rate of weight gain was calculated from 20 weeks to delivery (kg/week).  Recalled pregravid weight was used if it was within 5 kg of documented weight up to 10 weeks' gestation and within 7 kg of documented weight between 10 and 14 weeks gestation, otherwise the earliest prenatal wt (<14 weeks) was used.  Pregravid weight was recorded from the women's recalled weight (69%), from an early prenatal visit (23%) or was considered missing (8%).  Postpartum weight retention was calculated as measured weight at approximately 6 weeks post partum minus pregravid weight.

Women in the intervention group were seen at least monthly.

Dependent Variables

  • Improved dietary intake
  • Optimal gestational weight gain, glycemic levels and birth weight
  • Avoiding unnecessary postpartum weight retention

Independent Variables 

  • Diet and activity intervention 

Control Variables  Adjustment for intitial BMI, age and smoking appear to have been made for comparing infant birth weight, otherwise not described.

 

Description of Actual Data Sample:

Initial N: 219, 107 in the control period and 112 in the intervention period

Attrition (final N): Variable, not described

Age: 23. 8 +/- 5.86 years for controls, 24.3 +/- 6.29 years - not significantly different

Ethnicity: Cree

Other relevant demographics: Not described.

Anthropometrics

  • Prepregnancy weight: 78.9 kg (+17.54) controls, 81 kg (+19.46) intervention
  • Height: 163.2 cm (+5.71) controls, 162.0 cm (+5.04)
  • BMI: 29.6 (+6.45) controls, 30.8 (+6.85)
  • Gestational age at recruitment: 17.1 weeks (+7.06), 18.5 weeks (+6.92)

Location:  Cree communities

 

Summary of Results:

The intervention and control groups did not differ at baseline regarding their mean age, mean prepregnancy weight and mean gestational age.

The intervention did not result in differences in diet measured at 24-30 weeks' gestation, rate of weight gain over the 2nd half of pregnancy or plasma glucose level between 24 and 30 weeks.   Mean birth weights were similar as was maternal weight at 6 weeks post partum.

The only changes in dietary intake were a reduction in caffeine during pregnancy and an increase in folate post partum.

Variable N

Control Group

N

Intervention

Weight gain (kg/wk) 96

.53 (.32)

104

.53 (27)

Weight gain (kg/wk) BMI <29 49

.63 (.32)

51

.62 (.27)

Weight gain (kg/wk) BMI >29 47

.44 (.30)

53

.44 (.24)

Plasma glucose, mmol/L 87

7.21 (2.09)

97

7.43 (2.10)

Gestational age at delivery, wk 103

39.56 (1.87)

106

39.53 (3.42)

Birth wt, g 103

3741 (523)

106

3686 (686)

Birth weight > 4000 g (#, %) 103

31, 30.1%

106

37, 34.9%

Birth weight < 2500 g (#, %) 103

2, 1.94%

106

3, 2.83%

Birth weight ratio 103

1.15 (.18)

106

1.15 (.16)

C-section (#, %) 103

13, 12.62%

106

15, 14.15%

Postpartum weight, kg 75

88.1 (16.8)

62

86.4 (19.0)

Other Findings 

In the control group, there were 10 confirmed cases of GDM and an estimated additional 4 cases among those with a high glucose screen and no OGTT for a prevalence of 14.7%, 95;(7.58% - 21.8%).  In the intervention group, there were 15 confirmed and 3 estimated cases of GDM for a prevalence of 16.2%, 95; (9.15%-23.3%).   

A cross sectional analysis, controlling for the known effect of age on body weight by analysis of covariance, indicated that nulliparous women had a mean prepregnancy weight of 76.1 kg as opposed to 82.1 kg in parous women (p = .049).

Breast feeding at 6 weeks post partum was prevalent in both groups, with 83% of women in the control group and 87% of women in the intervention group breast-feeding their infants.  

During the postpartum period, energy intakes were higher than during pregnancy (p<.05). 

Author Conclusion:

The addition of 2 nutritionists was viewed as positive by the communities, but the intervention did not change any of the outcome measures. 

Energy intakes were high at 142 kJ/kg compared with recommended intakes of 105kJ/kg for overweight women and 146 kJ/kg for women of normal weight.  The dietary intake data indicated a direct correlation with weight gain.

The large amount of retained weight at 6 weeks post partum compounds the problem of being overweight and the high risk of type 2 diabetes in this population.

The reasons why the intervention was not successful have been reflected upon by all involved.  Discussions with women in the communities made it clear that being plump is desirable, whereas physical activity during pregnancy is not considered desirable, despite the fact that the older community members report that inactivity dring pregnancy is a recent phenomenon.

Funding Source:
Reviewer Comments:

One 24 hour recall is not likely to be sufficient to capture true dietary intake.  The results might have been more robust had they obtained more recalls and averaged the results.

Why the reported N changed and the reason for missing data is not described.

Six weeks is a very short period in which to measure postpartum weight loss. 

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
  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
  4. Is the intervention or procedure feasible? (NA for some epidemiological studies) Yes
 
Validity Questions
1. Was the research question clearly stated? Yes
  1.1. Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? Yes
  1.2. Was (were) the outcome(s) [dependent variable(s)] clearly indicated? Yes
  1.3. Were the target population and setting specified? 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
  2.2. Were criteria applied equally to all study groups? Yes
  2.3. Were health, demographics, and other characteristics of subjects described? Yes
  2.4. Were the subjects/patients a representative sample of the relevant population? Yes
3. Were study groups comparable? ???
  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
  3.3. 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? Yes
  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
4. Was method of handling withdrawals described? No
  4.1. Were follow-up methods described and the same for all groups? ???
  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%.) No
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? No
  4.4. Were reasons for withdrawals similar across groups? ???
  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? ???
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? ???
  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.) ???
  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
  5.5. 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
  6.1. 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? Yes
  6.3. Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? ???
  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? N/A
  6.6. Were extra or unplanned treatments described? N/A
  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
7. Were outcomes clearly defined and the measurements valid and reliable? ???
  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? No
  7.3. Was the period of follow-up long enough for important outcome(s) to occur? No
  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
  7.6. Were other factors accounted for (measured) that could affect outcomes? Yes
  7.7. Were the measurements conducted consistently across groups? N/A
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? ???
  8.1. Were statistical analyses adequately described and the results reported appropriately? ???
  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
  8.4. 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)? N/A
  8.5. Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? ???
  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? Yes
9. Are conclusions supported by results with biases and limitations taken into consideration? Yes
  9.1. Is there a discussion of findings? Yes
  9.2. Are biases and study limitations identified and discussed? Yes
10. Is bias due to study's funding or sponsorship unlikely? Yes
  10.1. Were sources of funding and investigators' affiliations described? Yes
  10.2. Was the study free from apparent conflict of interest? Yes